FDA 510(k) Applications for Medical Device Product Code "CGA"
(Glucose Oxidase, Glucose)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K873128 | A-KEM, INC. | GLUCOSE REAGENT KIT | 10/23/1987 |
| K863948 | ABBOTT LABORATORIES | A-GENT(TM) LIQUID GLUCOSE TRINDER | 11/13/1986 |
| K864224 | ABBOTT LABORATORIES | ABBOTT SPECTRUM GLUCOSE REAGENT | 01/05/1987 |
| K833069 | ABBOTT LABORATORIES | TDX GLUCOSE | 11/07/1983 |
| K103195 | ABBOTT POINT OF CARE INC. | I-STAT 1 WIRELESS ANALYZER | 02/08/2011 |
| K163271 | Abbott Point of Care, Inc. | i-Stat Alinity System with i-Stat Glucose test | 04/10/2017 |
| K183678 | Abbott point of Care, Inc. | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 02/07/2020 |
| K122110 | ACON LABORATORIES, INC. | ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM | 11/21/2012 |
| K111371 | ACON LABORATORIES, INC. | ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM | 10/06/2011 |
| K761153 | ADVANCED BIOMEDICAL METHODS, INC. | GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE | 12/09/1976 |
| K761154 | ADVANCED BIOMEDICAL METHODS, INC. | GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ | 12/09/1976 |
| K960337 | ADVANCED MEDICAL DEVICES, INC. | AMD HOME HEALTH MONITORING SYSTEM | 09/24/1996 |
| K120615 | ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN | ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE | 05/15/2013 |
| K082965 | ALLIANCE INTERNATIONAL CO., LTD. | DS-A BLOOD GLUCOSE MONITORING SYSTEM | 12/07/2009 |
| K851992 | ALPKEM CORP. | GLU(GOD) REAGENT | 05/29/1985 |
| K890336 | ALPKEM CORP. | GLUCOSE (GOD) REAGENT | 02/27/1989 |
| K875049 | AMATECH INTERNATIONAL, INC. | MD STRIPS BG | 08/23/1988 |
| K890524 | AMDEV, INC. | APEC GLUCOSE ANALYZER | 03/15/1989 |
| K043512 | AMERICAN HEALTHCARE INC. | EASYGLUCO IGM-0002 G2 | 04/08/2005 |
| K792534 | AMERICAN MONITOR CORP. | NEOCHROME II GLUCOSE, #4044 | 01/16/1980 |
| K892002 | AMERICAN MONITOR CORP. | NEOCHROME(R) III GLUCOSE | 06/12/1989 |
| K884909 | AMERICAN RESEARCH PRODUCTS CO. | GLUCOSE LIQUID AMRESCO #4628300 & 4628001L | 01/03/1989 |
| K882262 | AMERICAN RESEARCH PRODUCTS CO. | GLUCOSE-SUPER FAST 4983050 AND 4983500 | 02/02/1989 |
| K813168 | AMERICAN RESEARCH PRODUCTS CO. | LIQUIZYME GLUCOSE REAGENT | 12/03/1981 |
| K831634 | AMERICAN SCIENTIFIC PRODUCTS | GLUCOSE REAGENT B6360-11 | 07/19/1983 |
| K831624 | AMERICAN SCIENTIFIC PRODUCTS | GLUCOSE REAGENT KITS-B6370-10A | 07/06/1983 |
| K982076 | AMIRA MEDICAL, INC. | AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM | 12/10/1998 |
| K010605 | AMIRA MEDICAL, INC. | ATLAST DATA MANAGEMENT SOFTWARE (DMS) | 05/07/2001 |
| K811592 | AMRESCO, INC. | LIQUIZYME SINGLE SOLUTION GLUCOSE REAG | 07/01/1981 |
| K781307 | ANALYTICAL & RESEARCH CHEMICALS, INC. | GLUCOSE DETERM. KIT | 08/31/1978 |
| K931196 | APEC, INC. | APEC GLUCOSE ANALYZER | 12/07/1993 |
| K143750 | APEX BIO TECHNOLOGY CORP | MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System | 05/07/2015 |
| K131750 | APEX BIOTECHNOLOGY CORP. | AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM | 03/06/2014 |
| K090043 | APEX BIOTECHNOLOGY CORP. | AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 | 04/09/2009 |
| K102037 | APEX BIOTECHNOLOGY CORP. | AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS | 08/13/2010 |
| K113208 | APEX BIOTECHNOLOGY CORP. | GAL-1A BLOOD GLUCOSE MONITORING SYSTEM | 01/26/2012 |
| K113547 | APEX BIOTECHNOLOGY CORP. | GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL | 03/28/2012 |
| K142689 | Apex BioTechnology Corp. | GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System | 08/06/2015 |
| K062799 | APEX BIOTECHNOLOGY CORP. | GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM | 02/06/2007 |
| K002624 | APEX BIOTECHNOLOGY CORP. | GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM | 01/22/2001 |
| K002621 | APEX BIOTECHNOLOGY CORP. | GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM | 01/22/2001 |
| K073648 | APEX BIOTECHNOLOGY CORP. | GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 | 04/10/2008 |
| K101204 | APEX BIOTECHNOLOGY CORP. | MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION | 08/31/2011 |
| K120448 | APEX BIOTECHNOLOGY CORP. | MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL | 04/06/2012 |
| K011233 | APEX BIOTECHNOLOGY CORP. | MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 | 05/18/2001 |
| K893404 | APPRISE, INC. | INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM | 08/03/1989 |
| K124021 | ARKRAY FACTORY INC. | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM | 06/30/2014 |
| K142336 | ARKRAY FACTORY INC. | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System | 09/17/2014 |
| K073416 | ARKRAY Factory USA, Inc. | ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM | 06/13/2008 |
| K091102 | ARKRAY Factory USA, Inc. | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS | 10/23/2009 |
| K092104 | ARKRAY Factory USA, Inc. | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM | 11/24/2009 |
| K082417 | ARKRAY Factory USA, Inc. | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 | 10/21/2008 |
| K041427 | ARKRAY, INC. | THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS | 11/24/2004 |
| K972733 | AVL SCIENTIFIC CORP. | AVL OMNI ANALYZER | 09/09/1997 |
| K993837 | AVL SCIENTIFIC CORP. | AVL OPTI CRITICAL CARE ANALYZER | 12/16/1999 |
| K024062 | BAYER CORP. | ASCENSIA BREEZE BLOOD GLUCOSE METER | 03/03/2003 |
| K963500 | BAYER CORP. | GLUCOMETER DEX DIABETES CARE SYSTEM | 01/21/1997 |
| K964630 | BAYER CORP. | GLUCOMETER ELITE BLOOD GLUCOSE METER | 02/10/1997 |
| K951537 | BAYER CORP. | GLUCOMETER ELITE M BLOOD GLUCOSE METER | 07/14/1995 |
| K991242 | BAYER CORP. | GLUCOMETER ELITE TEST STRIPS | 06/30/1999 |
| K984006 | BAYER CORP. | GLUCOMETER ELITE XL BLOOD GLUCOSE METER | 03/18/1999 |
| K990649 | BAYER CORP. | GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS | 07/09/1999 |
| K893117 | BAYER CORP. | GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST | 06/16/1989 |
| K042015 | BAYER HEALTHCARE, DIAGNOSTICS DIVISION | ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE | 09/29/2004 |
| K842684 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | DIATROL BLOOD GLUCOSE TEST SYS | 09/07/1984 |
| K853656 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | QCA ENZYMATIC GLUCOSE | 09/16/1985 |
| K103842 | BECKMAN COULTER, INC. | UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 | 04/27/2011 |
| K761060 | BECKMAN INSTRUMENTS, INC. | GLUCOSE ANALYZER 2 | 01/25/1977 |
| K770200 | BECKMAN INSTRUMENTS, INC. | GO/HPO-GLUCOSE REAGENT (TRINDER) | 02/23/1977 |
| K041478 | BECTON DICKINSON | BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR | 10/28/2004 |
| K022580 | BECTON DICKINSON & CO. | BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM | 10/09/2002 |
| K103116 | BESTGEN BIOTECH CORP. | AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM | 03/13/2012 |
| K103230 | BESTGEN BIOTECH CORP. | AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION | 04/24/2012 |
| K910692 | BIO SCAN INSTRUMENT, INC. | BIO SCAN-BG(TM | 03/29/1991 |
| K871650 | BIOCHEMICAL TRADE, INC. | GLUCOSE ENZYME - COLOR REAGENT SET | 05/12/1987 |
| K850257 | BIOCLINICAL SYSTEMS, INC. | BCS GLUCOSE COLORIMETRIC TEST | 03/05/1985 |
| K821091 | BIODYNAMICS CORP. | ACCUCHEK BG. | 05/14/1982 |
| K820465 | BIODYNAMICS CORP. | CHEMSTRIP UG | 03/11/1982 |
| K033627 | BIOMEDIX, INC. | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM | 05/21/2004 |
| K050182 | BIOMEDIX, INC. | Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM | 08/09/2005 |
| K813555 | BIORENT DIAGNOSTIC, INC. | GLUCOSE ENZYME-COLOR REAGENT SET | 01/18/1982 |
| K873117 | BIOTROL, USA, INC. | BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT | 08/31/1987 |
| K904168 | BOEHRINGER MANNHEIM CORP. | ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM | 10/15/1990 |
| K930979 | BOEHRINGER MANNHEIM CORP. | ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM | 09/08/1993 |
| K952875 | BOEHRINGER MANNHEIM CORP. | ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS | 11/21/1995 |
| K923048 | BOEHRINGER MANNHEIM CORP. | ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM | 10/14/1992 |
| K851456 | BOEHRINGER MANNHEIM CORP. | ACCU-CHEK II | 08/01/1985 |
| K944459 | BOEHRINGER MANNHEIM CORP. | ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM | 04/17/1996 |
| K904292 | BOEHRINGER MANNHEIM CORP. | ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM | 10/22/1990 |
| K883817 | BOEHRINGER MANNHEIM CORP. | ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM | 12/09/1988 |
| K924475 | BOEHRINGER MANNHEIM CORP. | ACCUDATA GLUCOSE TEST STATION | 10/13/1992 |
| K842393 | BOEHRINGER MANNHEIM CORP. | BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE | 08/16/1984 |
| K863481 | BOEHRINGER MANNHEIM CORP. | MODIFICATION OF ACCU-CHEK II | 04/07/1987 |
| K834271 | BOEHRINGER MANNHEIM CORP. | REFLOCHECK & GLUCOSE TEST STRIP SYS | 02/13/1984 |
| K840962 | BOEHRINGER MANNHEIM CORP. | REFLOCHECK-S | 06/22/1984 |
| K761148 | BOEHRINGER MANNHEIM CORP. | REFLOMAT/REFLOTEST SYSTEM | 02/11/1977 |
| K781075 | BOEHRINGER MANNHEIM CORP. | STATTEK-GLUCOSE LOW LEVEL | 08/14/1978 |
| K881908 | BOEHRINGER MANNHEIM CORP. | TRACER(TM) II BLOOD GLUCOSE SYSTEM | 07/12/1988 |
| K860948 | BOEHRINGER MANNHEIM CORP. | TRACKER SYSTEM | 12/08/1986 |
| K911596 | BRITISH-AMERICAN MEDICAL, INC. | VISION BG MONITOR | 05/15/1991 |
| K911624 | BRITISH-AMERICAN MEDICAL, INC. | VISION BG TEST STRIP | 07/17/1991 |
| K102316 | BROADMASTER BIOTECH CORPORATION | GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM | 10/07/2011 |
| K061528 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | SELFCHECK GLUCO | 09/22/2006 |
| K922035 | CARO MED, INC. | GLUCOSE 3 | 09/23/1992 |
| K910573 | CARO MED, INC. | GLUCOSE V | 04/03/1991 |
| K896144 | CASCADE MEDICAL, INC. | AUTOSCAN, AUTOSTRIP AND AUTOCONTROL | 12/19/1989 |
| K931188 | CASCADE MEDICAL, INC. | CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC | 05/26/1993 |
| K021781 | CHAY MEDICAL, LLC. | EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS | 08/30/2002 |
| K013342 | CHAY MEDICAL, LLC. | EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. | 02/15/2002 |
| K943503 | CHEM-ELEC, INC. | CHEMCARD GLUCOSE TEST | 07/23/1996 |
| K811165 | CHEM-ELEC, INC. | GLUCOSE OXIDASE RATE REAGENT | 08/13/1981 |
| K932727 | CHOLESTECH CORP. | CHOLESTECH L.D.X. SYSTEM | 11/09/1993 |
| K904082 | CHOLESTECH CORP. | CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST | 12/26/1990 |
| K980573 | CHRONIMED, INC. | SENSOREX BLOOD GLUCOSE MONITORING SYSTEM | 07/30/1998 |
| K963544 | CHRONIMED, INC. | SUPREME II METER | 02/20/1997 |
| K854177 | CLINICAL DATA, INC. | IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE | 11/25/1985 |
| K940215 | CLINICAL DIAGNOSTICS, INC. | GLUCOCHEK | 01/17/1995 |
| K951457 | CLINICAL DIAGNOSTICS, INC. | GLUCOCHEK POCKETLAB | 02/22/1996 |
| K971653 | CLINICAL DIAGNOSTICS, INC. | GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM | 01/02/1998 |
| K801897 | CONNECTICUT DIAGNOSTICS, LTD. | GLUCOSE DIAGNOSTIC REAGENT | 10/10/1980 |
| K003257 | CYBERCARE TECHNOLOGIES, INC. | EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION | 12/22/2000 |
| K983344 | DADE BEHRING, INC. | DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL | 06/22/1999 |
| K943241 | DATA MEDICAL ASSOCIATES, INC. | DMA GLUCOSE (OXIDASE) PROCEDURE | 10/20/1994 |
| K861653 | DATA MEDICAL ASSOCIATES, INC. | GLUCOSE HK PROCEDURE | 05/23/1986 |
| K861204 | DATA MEDICAL ASSOCIATES, INC. | GLUCOSE OXIDASE PROCEDURE | 04/24/1986 |
| K855178 | DEXTRON, INC. | DIATRON BLOOD GLUCOSE METER | 08/04/1986 |
| K875211 | DIAGNOSTIC CHEMICALS, LTD. (USA) | GLUCOSE (TRINDER) CAT. # 220-32 | 04/18/1988 |
| K842506 | DIAGNOSTIC CHEMICALS, LTD. (USA) | GLUCOSE-TRINDER-ADDAY KIT | 07/19/1984 |
| K891050 | DIAGNOSTIC RESOURCES, INC. | STAT CHEM SYSTEM | 07/20/1989 |
| K921825 | DIAGNOSTIC SOLUTIONS, INC. | QUICK-CHECK II REAGENT STRIP | 08/18/1992 |
| K800687 | DIAGNOSTIC SOLUTIONS, INC. | REAGENT FOR DETERM. GLUCOSE IN H/SERUM | 05/28/1980 |
| K934892 | DIAGNOSTIC SOLUTIONS, INC. | RELIEF PLUS ONE REAGENT STRIP MODIFICATION | 01/11/1994 |
| K924398 | DIAGNOSTIC SOLUTIONS, INC. | UNI-CHECK REAGENT STRIP | 12/23/1992 |
| K813412 | DIAGNOSTIC SPECIALTIES | GLUCOSE ENZYME-COLOR REAGENT SET | 12/31/1981 |
| K884993 | DIAGNOSTIC SYSTEMS | VISUAL BLOOD GLUCOSE TEST SYSTEM | 12/29/1988 |
| K033055 | DIAMOND DIAGNOSTICS, INC. | GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS | 01/30/2004 |
| K101741 | DIATRON GROUP | DIATRON PICTUS 400 | 01/25/2011 |
| K863223 | DIMENSION DIAGNOSTICS | DIMENSION-WBG | 03/10/1987 |
| K872889 | DIVA MEDICAL SYSTEMS, INC. | ROMEO(TM) MODEL 1000 | 04/13/1988 |
| K070704 | DREW SCIENTIFIC, INC. | TRILOGY ANALYZER | 07/13/2007 |
| K843151 | EM DIAGNOSTIC SYSTEMS, INC. | SYSTEMATE GLUCOSE 67215 | 08/27/1984 |
| K133584 | EOSHEALTH, INC. | IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM | 09/08/2014 |
| K090109 | EPOCAL, INC. | BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD | 06/24/2009 |
| K082121 | EPS BIO TECHNOLOGY CORP. | EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 | 09/17/2008 |
| K061992 | EPS BIO TECHNOLOGY CORP. | EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 | 09/19/2006 |
| K111728 | EPS BIO TECHNOLOGY CORP. | EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | 09/16/2011 |
| K043245 | EPS BIO TECHNOLOGY CORP. | EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM | 04/29/2005 |
| K062892 | EUMED BIOTECHNOLOGY CO., LTD. | EUKARE | 01/22/2007 |
| K981183 | EXIGENT DIAGNOSTICS, INC. | CARESIDE GLUCOSE | 05/07/1998 |
| K810567 | FERMCO BIOCHEMICS, INC. | GERMCO TEST R GLUCOSE TEST KIT | 03/13/1981 |
| K791066 | FERMCO BIOCHEMICS, INC. | GLUCOSE GOD-PAP TRINDER METHOD TEST KIT | 09/04/1979 |
| K781945 | FERMCO BIOCHEMICS, INC. | GLUCOSE OXIDASE REAGENT | 01/17/1979 |
| K955107 | FIREHOUSE MEDICAL, INC. | SAFESTRIP | 08/16/1996 |
| K800070 | FISHER SCIENTIFIC CO., LLC. | GLUCOSE OXIDASE REAGENT KIT | 02/05/1980 |
| K121706 | FORA CARE INC. | FORA V10 BLOOD GLUCOSE MONITORING SYSTEM | 01/14/2013 |
| K860682 | GAMBRO, INC. | GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET | 08/29/1986 |
| K853733 | GARID, INC. | MED-PEN/MED-POINT | 12/04/1986 |
| K872049 | GARID, INC. | NOVOCHECK/CHECKPOINT/CONTROL SOLUTION | 08/13/1987 |
| K971145 | GDS TECHNOLOGY, LLC. | GLUCOSITE TEST SYSTEM | 09/17/1997 |
| K040974 | GENCHEM, INC. | GLUCOSE OXIDASE, GLUCOSE | 12/27/2004 |
| K801600 | GILFORD DIAGNOSTICS | GLUCOSE (TRINDER) REAGENT | 08/27/1980 |
| K812258 | HARLECO | ACR ENZYMATIC GLUCOSE OXIDASE | 08/31/1981 |
| K771754 | HARLECO | GLUCOSE REAGENT FOR GLUC. ANALYZER | 10/18/1977 |
| K780093 | HARLECO | GLUCOSE REAGENT FOR GLUCOSE ANALYZER | 02/13/1978 |
| K993128 | HEALTH HERO NETWORK, INC. | HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] | 11/23/1999 |
| K842207 | HEALTHDYNE, INC. | WAKO B.G. PRETEST STRIPS | 06/26/1984 |
| K943432 | HEMOCUE, INC. | HEMOCUE B-GLUCOSE SYSTEM | 01/17/1995 |
| K020935 | HEMOCUE, INC. | HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 | 04/03/2002 |
| K911141 | HEMOCUE, INC. | HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER | 05/08/1991 |
| K884756 | HERAEUS KULZER, INC. | CLINISTAT GLUCOSE REAGENT TEST | 01/13/1989 |
| K924499 | HERAEUS KULZER, INC. | ELITE TEST STRIPS GLUCOMETER | 12/17/1992 |
| K926360 | HERAEUS KULZER, INC. | GLUCOFILM TEST STRIPS | 09/08/1993 |
| K936212 | HERAEUS KULZER, INC. | GLUCOFILM TEST STRIPS | 05/10/1994 |
| K890873 | HERAEUS KULZER, INC. | GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3 | 04/04/1989 |
| K897015 | HERAEUS KULZER, INC. | GLUCOMETER GX BLOOD GLUCOSE METER | 03/29/1990 |
| K931310 | HERAEUS KULZER, INC. | GLUCOMETER M+ BLOOD GLUCOSE METER | 06/25/1993 |
| K904081 | HERAEUS KULZER, INC. | GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM | 12/26/1990 |
| K934898 | HERAEUS KULZER, INC. | GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION | 12/07/1993 |
| K926362 | HERAEUS KULZER, INC. | GLUCOSTIX REAGENT STRIPS | 11/10/1993 |
| K813370 | HI CHEM, INC. | ELECTROLYTE GEL | 12/22/1981 |
| K791685 | HI CHEM, INC. | GLUCOSE REAGENT | 09/17/1979 |
| K771000 | HI CHEM, INC. | TRENDAR | 07/15/1977 |
| K925551 | HICHEM DIAGNOSTICS | HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 | 04/20/1993 |
| K915772 | HOME DIAGNOSTICS, INC. | DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP | 04/14/1992 |
| K922137 | HOME DIAGNOSTICS, INC. | DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP | 08/10/1993 |
| K851618 | HOME DIAGNOSTICS, INC. | DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS | 08/06/1985 |
| K872505 | HOME DIAGNOSTICS, INC. | DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS | 10/20/1987 |
| K960855 | HOME DIAGNOSTICS, INC. | PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL | 11/07/1996 |
| K992988 | HOME DIAGNOSTICS, INC. | PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM | 09/24/1999 |
| K912440 | HOME DIAGNOSTICS, INC. | ULTRA BLOOD GLUCOSE MONITORING SYSTEM | 07/17/1991 |
| K922136 | HOME DIAGNOSTICS, INC. | ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP | 08/10/1993 |
| K915770 | HOME DIAGNOSTICS, INC. | ULTRA+ BLOOD GLUCOSE TEST STRIP | 04/14/1992 |
| K080636 | HUBDIC CO., LTD | DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 | 02/13/2009 |
| K041881 | HYPOGUARD USA, INC. | ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 | 03/25/2005 |
| K053079 | HYPOGUARD USA, INC. | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 | 03/28/2006 |
| K024347 | HYPOGUARD USA, INC. | EXPRESS BLOOD GLUCOSE MONITORING SYSTEM | 03/28/2003 |
| K020232 | HYPOGUARD USA, INC. | HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM | 02/12/2002 |
| K031388 | HYPOGUARD USA, INC. | MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM | 05/22/2003 |
| K103278 | i-SENS, Inc. | ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION | 10/28/2011 |
| K121654 | i-SENS, Inc. | AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION | 09/05/2012 |
| K120759 | i-SENS, Inc. | CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION | 06/05/2012 |
| K001387 | I-STAT CORP. | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 | 10/05/2000 |
| K770317 | ICN PHARMACEUTICALS, INC. | GLUCOSE TRINDER, ENZYMATIC | 03/30/1977 |
| K001092 | INBIOS INTL., INC. | GENERIC BLOOD GLUCOSE TEST STRIP | 07/26/2000 |
| K052207 | INCLINE MEDICAL, LLC | ACCUREX GLUCOSE TEST STRIP | 03/09/2006 |
| K113670 | INFOPIA CO., LTD | ELEMENT BLOOD GLUCOSE MONITORING SYSTEM | 05/08/2012 |
| K051285 | INFOPIA CO., LTD | GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM | 08/02/2005 |
| K153692 | INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) | Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer | 06/24/2016 |
| K052121 | INSTRUMENTATION LABORATORY CO. | GEM PREMIER 3000 | 10/21/2005 |
| K161818 | Instrumentation Laboratory Co. | GEM Premier 3000 | 09/14/2016 |
| K010520 | INSTRUMENTATION LABORATORY CO. | GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS | 05/07/2001 |
| K160402 | Instrumentation Laboratory Co. | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | 12/14/2016 |
| K183546 | Instrumentation Laboratory Co. | GEM Premier ChemSTAT | 02/16/2019 |
| K922532 | INSTRUMENTATION LABORATORY CO. | IL TEST GLUCOSE, PN 181633-80 | 09/30/1992 |
| K022158 | INSTRUMENTATION LABORATORY CO. | IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) | 09/10/2002 |
| K771471 | INSTRUMENTATION LABORATORY CO. | MULTISTAT III GLUCOSE TEST | 09/12/1977 |
| K091975 | INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC. | INTEGRATED LABORATORY AUTOMATION SOLUTION | 03/10/2010 |
| K870616 | INTERSECT SYSTEMS, INC. | GLUCOSE OXIDASE REAGENT | 03/06/1987 |
| K011479 | INVERNESS MEDICAL INNOVATIONS, INC. | ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | 11/30/2001 |
| K863102 | J. D. ASSOC. | GLUCOMETER-E | 11/24/1986 |
| K772308 | J.T. BAKER CHEMICAL CO. | AUTOZYME GLUCOSE OXIDASE (TRINDER) | 03/03/1978 |
| K771059 | J.T. BAKER CHEMICAL CO. | DIAG. OZYRATE GLUCOSE REAG. SET | 07/21/1977 |
| K955286 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) | 05/17/1996 |
| K831411 | KING DIAGNOSTICS, INC. | GLUCOSE OXIDASE/PEROXIDASE TEST | 07/06/1983 |
| K811882 | KING DIAGNOSTICS, INC. | KING DIAGNOSTICS GLUCOSE TEST | 07/23/1981 |
| K843003 | KYOTO DIAGNOSTICS, INC. | GLUCOSE AUTO& STAT GA-1120 | 09/28/1984 |
| K871586 | LARKEN INDUSTRIES, INC. | GLUCOCHEK S.C. WITH AUDIO OPTION | 09/16/1987 |
| K822699 | LIFESCAN, INC. | GLUCOSCAN METER MODEL II | 11/05/1982 |
| K822697 | LIFESCAN, INC. | GLUCOSCAN TEST STRIPS | 09/30/1982 |
| K810993 | LIFESCAN, INC. | GLUCOSCAN TEST STRIPS | 04/29/1981 |
| K984527 | LIFESCAN, INC. | IN TOUCH DIABETES MANAGEMENT SOFTWARE | 04/29/1999 |
| K942455 | LIFESCAN, INC. | LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM | 03/24/1995 |
| K864322 | LIFESCAN, INC. | MPX SYSTEM, GLUCOSE TEST SYSTEM | 02/25/1987 |
| K031472 | LIFESCAN, INC. | ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS | 08/05/2003 |
| K950816 | LIFESCAN, INC. | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM | 07/03/1995 |
| K974451 | LIFESCAN, INC. | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM | 01/26/1998 |
| K972473 | LIFESCAN, INC. | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK | 12/16/1997 |
| K895911 | LIFESCAN, INC. | ONE TOUCH II METER | 11/08/1989 |
| K922888 | LIFESCAN, INC. | ONE TOUCH IIB BLOOD GLUCOSE METER | 09/15/1992 |
| K950727 | LIFESCAN, INC. | ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM | 06/01/1995 |
| K923544 | LIFESCAN, INC. | ONE TOUCH TEST STRIPS | 12/03/1992 |
| K913357 | LIFESCAN, INC. | ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST | 11/07/1991 |
| K021943 | LIFESCAN, INC. | ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM | 06/28/2002 |
| K043197 | LIFESCAN, INC. | ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM | 05/20/2005 |
| K001441 | LIFESCAN, INC. | SATURN BLOOD GLUCOSE MONITORING TEST STRIP | 12/18/2000 |
| K984261 | LIFESCAN, INC. | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM | 05/21/1999 |
| K970556 | LIFESCAN, INC. | SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM | 05/12/1997 |
| K023194 | LIFESCAN, INC. | SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM | 10/24/2002 |
| K922207 | LILLY RESEARCH LABORATORIES | TES-TAPE | 06/15/1993 |
| K843528 | LIVONIA DIAGNOSTICS, INC. | GLUCOSE OXIDASE ENZYMATIC REAGENT SET | 09/28/1984 |
| K973140 | LXN CORP. | DUET GLUCOSE CONTROL MONITORING SYSTEM | 10/31/1997 |
| K990942 | LXN CORP. | DUET II GLUCOSE CONTROL MONITORING SYSTEM | 08/02/1999 |
| K991754 | LXN CORP. | GO GLUCOSE MONITORING SYSTEM | 09/08/1999 |
| K960034 | LXN CORP. | LXN BLOOD GLUCOSE TEST SYSTEM | 06/28/1996 |
| K002688 | LXN CORP. | PERSONAL GLUCOSE CONTROL CHARTING SYSTEM | 02/01/2001 |
| K880585 | MACH DIAG. C/O WICHITA STATE UNIVERSITY | DEXPAD, BLOOD GLUCOSE STRIP | 04/18/1988 |
| K791669 | MACOMB CHEMICAL CO. | GLUCOSE OXIDASE REAGENT SET | 09/24/1979 |
| K070057 | MEDICA CORP. | EASYRA CLINICAL CHEMISTRY ANALYZER | 08/30/2007 |
| K100187 | MEDICA CORP. | EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT | 05/05/2010 |
| K864282 | MEDICAL DEVICE CONSULTANTS, INC. | GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA | 05/26/1987 |
| K841055 | MEDICAL SPECIALTIES, INC. | GLUCOSE ENZYMATIC REAGENT SET | 05/01/1984 |
| K961337 | MEDISENSE, INC. | EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM | 06/21/1996 |
| K901613 | MEDISENSE, INC. | MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM | 07/10/1990 |
| K963676 | MEDISENSE, INC. | PRECISION G BLOOD GLUCOSE TESTING SYSTEM | 02/20/1997 |
| K952279 | MEDISENSE, INC. | PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM | 06/14/1995 |
| K982303 | MEDISENSE, INC. | PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST | 12/08/1998 |
| K945887 | MEDISENSE, INC. | PRECISION Q I D BLOOD GLUCOSE TEST STRIPS | 03/23/1995 |
| K962295 | MEDISENSE, INC. | PRECISION QID BLOOD GLUCOSE TEST STRIP | 07/26/1996 |
| K971812 | MEDISENSE, INC. | PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP | 08/08/1997 |
| K983504 | MEDISENSE, INC. | PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST | 07/09/1999 |
| K944195 | MEDISENSE, INC. | QUICKPRO BLOOD GLUCOSE TESTING SYSTEM | 03/23/1995 |
| K896951 | MEDISENSE, INC. | SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM | 02/26/1990 |
| K840484 | MEDIVIX, INC. | DIATRON EASYTEST BLOOD GLUCOSE MONI | 06/22/1984 |
| K791869 | MID TECH, INC. | GLUCOSE OXIDASE (FRINDER) KIT | 10/01/1979 |
| K821247 | MILES LABORATORIES, INC. | ACCUDEX REAGENT STRIPS | 05/21/1982 |
| K811392 | MILES LABORATORIES, INC. | AMES SERA-PAK GLUCOSE REAGENT | 05/29/1981 |
| K780393 | MILES LABORATORIES, INC. | BIOSTATOR GLUCOSE ANALYZER | 06/19/1978 |
| K861303 | MILES LABORATORIES, INC. | GLUCOMETER II "IMPROVED" REFLECTANCE PHOTOMETER | 07/02/1986 |
| K855202 | MILES LABORATORIES, INC. | GLUCOMETER M BLOOD GULCOSE METER | 07/02/1986 |
| K871835 | MILES LABORATORIES, INC. | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT | 12/22/1987 |
| K851703 | MILES LABORATORIES, INC. | GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT | 08/23/1985 |
| K864530 | MILES LABORATORIES, INC. | SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. | 02/18/1987 |
| K801663 | MILES LABORATORIES, INC. | SERALYZER GLUCOSE REAGENT STRIPS | 08/20/1980 |
| K810639 | MILES LABORATORIES, INC. | SERALYZER SYSTEM | 03/31/1981 |
| K831989 | MILES LABORATORIES, INC. | VISIDEX II REAGENT STRIPS | 08/08/1983 |
| K821179 | MILES LABORATORIES, INC. | VISIDEX REAGENT STRIPS | 05/14/1982 |
| K812866 | NOBEL SCIENTIFIC INDUSTRIES, INC. | ASTRA REAGENT CONCENTRATE SYSTEM | 12/17/1981 |
| K800589 | NOBEL SCIENTIFIC INDUSTRIES, INC. | GLUCOSE OXIDASE REAGENT | 04/04/1980 |
| K761181 | NOBEL SCIENTIFIC INDUSTRIES, INC. | GLUCOSE OXIDASE REAGENT SYSTEM | 12/13/1976 |
| K924743 | NOVA BIOMEDICAL CORP. | NOVA 12 ANALYZER, MODIFICATION | 11/06/1992 |
| K063821 | NOVA BIOMEDICAL CORP. | NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | 01/24/2007 |
| K060345 | NOVA BIOMEDICAL CORP. | NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS | 04/28/2006 |
| K070960 | NOVA BIOMEDICAL CORP. | NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM | 07/11/2007 |
| K180340 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | 09/26/2018 |
| K200349 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | 03/13/2020 |
| K821204 | OMEGA MEDICAL ELECTRONICS | GLUCOSE(ENZYMATIC) REAGENT SET | 07/22/1982 |
| K841369 | ORANGE MEDICAL INSTRUMENTS, INC. | BETA SCAN DRYSTIX | 08/23/1984 |
| K832691 | ORANGE MEDICAL INSTRUMENTS, INC. | BETA SCAN REAGENT STRIP | 11/14/1983 |
| K851822 | ORANGE MEDICAL INSTRUMENTS, INC. | BETA SCAN TRENDS METER | 10/03/1985 |
| K163433 | Ortho Clinical Diagnostics | VITROS Chemistry Products GLU Slides | 09/18/2017 |
| K190520 | Ortho-Clinical Diagnostics, Inc. | VITROS XT Chemistry Products GLU-Ca Slides | 04/03/2019 |
| K822486 | PHARMAQUEST CORP. | HOME BLOOD GLUCOSE MONITOR | 11/05/1982 |
| K822976 | PHARMAQUEST CORP. | HYPOCOUNT A | 11/16/1982 |
| K113636 | PHILOSYS CO. LTD. | BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) | 03/08/2013 |
| K780512 | PIERCE CHEMICAL CO. | AUTO/STAT KIT | 05/03/1978 |
| K810674 | POINTE SCIENTIFIC, INC. | GLUCOSE OXIDASE | 03/31/1981 |
| K970781 | POINTE SCIENTIFIC, INC. | LIQUID GLUCOSE (OXIDASE) REAGENT SET | 04/21/1997 |
| K912580 | POLYMER TECHNOLOGY CORP. | FIRST CHOICE | 03/04/1992 |
| K893205 | POLYMER TECHNOLOGY CORP. | FIRST CHOICE (TM) | 10/06/1989 |
| K912732 | POLYMER TECHNOLOGY CORP. | FIRST CHOICE(TM) | 09/10/1991 |
| K911792 | POLYMER TECHNOLOGY CORP. | FIRST CHOICE(TM), MODIFICATION | 05/15/1991 |
| K923587 | POLYMER TECHNOLOGY CORP. | GLUCOSE TEST SYSTEM | 12/28/1992 |
| K950628 | POLYMER TECHNOLOGY INTL. | FIRST CHOICE TEST STRIP | 11/08/1995 |
| K946166 | POLYMER TECHNOLOGY INTL. | FIRST CHOICE(TM) TEST STRIP | 11/08/1995 |
| K013068 | POLYMER TECHNOLOGY SYSTEMS, INC. | BIOSCANNER 2000 | 11/20/2001 |
| K142302 | Polymer Technology Systems, Inc. | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemis | 10/02/2014 |
| K151530 | POLYMER TECHNOLOGY SYSTEMS, INC. | CardioChek Plus Test System | 07/07/2015 |
| K972669 | POLYMER TECHNOLOGY SYSTEMS, INC. | MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON | 01/22/1998 |
| K162282 | Polymer Technology Systems, Inc. d/b/a PTS Diagnostics | CardioChek Plus Test System, CardioChek Home Test System | 12/22/2016 |
| K182781 | Polymer Technology Systems, Inc. d/b/a PTS Diagnostics | PTS Professional Chemistry Kit | 12/21/2018 |
| K760347 | PRINCETON BIOMEDIX | SET, TRINDER GLUCOSE | 10/05/1976 |
| K880703 | QUANTAI BIOTRONICS, INC. | QUANTAI BG(TM) REAGENT STRIP | 07/08/1988 |
| K893661 | QUANTAI BIOTRONICS, INC. | QUANTAI UG REAGENT STRIP | 11/08/1989 |
| K903191 | QUANTAI BIOTRONICS, INC. | QUICK CHECK 3 FILM | 10/15/1990 |
| K952621 | RADIOMETER AMERICA, INC. | EML105 ELECTROLYTE METABOLITE ANALYZER | 10/17/1995 |
| K003346 | RANDOX LABORATORIES, LTD. | RANDOX GLUCOSE (GOD/PAP) | 03/15/2001 |
| K024014 | RANDOX LABORATORIES, LTD. | RANDOX RX DAYTONA | 12/04/2003 |
| K811074 | REAGENTS APPLICATIONS, INC. | GLUCOSE REAGENT-ENZYMATIC-COLOR 500 | 04/29/1981 |
| K895526 | ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS READY GLUCOSE REAGENT | 10/16/1989 |
| K890528 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE CHLORIDE ELECTRODE | 03/31/1989 |
| K000365 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK ADVANTAGE METER | 02/23/2000 |
| K001907 | ROCHE DIAGNOSTICS CORP. | CAMIT DIABETES MANAGEMENT SOFTWARE | 09/05/2000 |
| K014139 | ROCHE DIAGNOSTICS CORP. | DIABETES ASSISTANT SOFTWARE | 03/21/2002 |
| K870631 | SCLAVO, INC. | FAST GLUCOSE | 03/13/1987 |
| K961985 | SELFCARE, INC. | ELECT BLOOD GLUCOSE MONITORIG SYSTEM | 09/05/1996 |
| K970707 | SELFCARE, INC. | ELECT II BLOOD GLUCOSE MONITORING SYSTEM | 06/20/1997 |
| K991480 | SELFCARE, INC. | EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP | 09/17/1999 |
| K990939 | SELFCARE, INC. | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | 04/20/1999 |
| K993632 | SELFCARE, INC. | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | 11/12/1999 |
| K000583 | SELFCARE, INC. | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | 03/17/2000 |
| K001427 | SELFCARE, INC. | MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | 06/02/2000 |
| K002134 | SELFCARE, INC. | ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | 08/07/2000 |
| K960053 | SELFCARE, INC. | SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM | 06/28/1996 |
| K854260 | SEN TECH MEDICAL CORP. | CHEMPRO 1000 | 11/19/1985 |
| K151639 | SENDX MEDICAL INC | ABL80 FLEX and ABL80 FLEX CO-OX | 12/07/2015 |
| K100525 | SEPPIM S.A.S. | ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 | 12/15/2010 |
| K832926 | SERAGEN DIAGNOSTICS, INC. | ENZYMATIC GLUCOSE DETERMINATION | 10/28/1983 |
| K854329 | SETON PRODUCTS, INC. | DIAGEM 300 BG REAGENT STRIPS | 08/04/1986 |
| K822958 | SHERWOOD MEDICAL CO. | LANCER MSH GLUCOSE DIAG. KIT | 11/05/1982 |
| K801071 | SHERWOOD MEDICAL INDUSTRIES | LANCER GLUCOSE RATE REAGENT KIT | 05/23/1980 |
| K850364 | SIGMA CHEMICAL CO. | GLUCOSE - TRINDER- REAGENT | 03/05/1985 |
| K933694 | SIGMA CHEMICAL CO. | SIGMA GLUCOSE REAGENT | 11/04/1994 |
| K852130 | SIGMA DIAGNOSTICS, INC. | GLUCOSE(TRINDER) REAGENT | 06/10/1985 |
| K963535 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS GLUCOSE REAGENT | 01/17/1997 |
| K800200 | SIMMLER, INC. | LINEAR ENZYMATIC GLUCOSE SYSTEM | 02/21/1980 |
| K120921 | SIMPLE DIAGNOSTICS, INC. | CLEVER CHOICE | 08/21/2012 |
| K101947 | SPHERE MEDICAL LTD. | IVD-GE02 | 03/16/2011 |
| K832159 | STANBIO LABORATORY | UNITIZED ENZYMATIC GLUCOSE TEST SET | 08/16/1983 |
| K854335 | STERLING DIAGNOSTICS, INC. | GLUCOSE REAGENT SET (GOD/TRINDER) | 11/22/1985 |
| K903063 | SYNERMED, INC. | SYNERMED GLUCOSE REAGENT KIT | 09/13/1990 |
| K081609 | TaiDoc Technology Corporation | CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 | 07/02/2008 |
| K093506 | TaiDoc Technology Corporation | CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267 | 04/01/2010 |
| K093941 | TaiDoc Technology Corporation | CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 | 03/26/2010 |
| K091814 | TaiDoc Technology Corporation | FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE | 11/20/2009 |
| K100405 | TaiDoc Technology Corporation | FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM | 07/09/2010 |
| K081714 | TaiDoc Technology Corporation | FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM | 07/25/2008 |
| K083664 | TaiDoc Technology Corporation | FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 | 01/09/2009 |
| K082482 | TaiDoc Technology Corporation | FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254 | 01/30/2009 |
| K100406 | TaiDoc Technology Corporation | FORA V20 BLOOD GLUCOSE MONITORING SYSTEM | 05/11/2010 |
| K083570 | TaiDoc Technology Corporation | U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM | 03/11/2009 |
| K914159 | TECH INTL. CO. | GLUCOSE REAGENT SET | 01/27/1992 |
| K863926 | TECH-CO, INC. | GLUCOSE OXIDASE | 11/13/1986 |
| K791989 | TECHNICON INSTRUMENTS CORP. | TECHNICON C202 SYSTEM | 10/17/1979 |
| K855194 | TECHNOSTICS INTL. | GLUCOSE OXIDASE REAGENT SET | 01/14/1986 |
| K823474 | THE DOW CHEMICAL CO. | ENZYMATIC GLUCOSE DETERMINATION | 12/30/1982 |
| K863468 | TRAVENOL LABORATORIES, S.A. | EXACTECH(TM) | 12/08/1986 |
| K862721 | U. S. DIAGNOSTICS, INC. | ENZYMATIC BLOOD GLUCOSE | 09/03/1986 |
| K831194 | ULSTER SCIENTIFIC, INC. | GLUCOKEY | 10/31/1983 |
| K862984 | UNIDEX, INC. | UNIDEX GLUCOSE TEST STRIP | 11/05/1986 |
| K852960 | UNIVERSITY OF WISCONSIN | DIRECT | 06/16/1986 |
| K061431 | US DIAGNOSTICS, INC. | EASYGLUCO, MODEL IGM-0002 G2 | 01/12/2007 |
| K792398 | VOLU SOL MEDICAL INDUSTRIES | ELVI GLUCOSE | 12/07/1979 |
| K950172 | WAKO CHEMICALS, USA, INC. | WAKO AUTOKIT GLUCOSE | 10/05/1995 |
| K833257 | WAKO CHEMICALS, USA, INC. | WAKO GLUCOSE C | 12/08/1983 |
| K781342 | WAKO INTL., INC. | GLUCOSE TEST | 08/31/1978 |
| K842221 | WAKO PURE CHEMICAL INDUSTRIES, LTD. | WAKO GLUCOSE C | 07/12/1984 |
| K011953 | WIENER LABORATORIES S.A.I.C. | WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA | 12/21/2001 |
| K771001 | WORTHINGTON BIOCHEMICAL CORP. | STATZYME GLUCOSE | 07/11/1977 |
| K821192 | YELLOW SPRINGS INSTRUMENT CO., INC. | YSI #24 & 24M GLUCOSE ANALYZERS | 06/14/1982 |
| K910633 | YELLOW SPRINGS INSTRUMENT CO., INC. | YSI MODEL 1500 BLOOD GLUCOSE ANALYZER | 04/12/1991 |
| K891480 | YELLOW SPRINGS INSTRUMENT CO., INC. | YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER | 05/22/1989 |
| K913806 | YSIS, INC | YSI MODEL 2300 STAT PLUS | 10/02/1991 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
