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 |
| 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 |
| K922137 | HOME DIAGNOSTICS, INC. | DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP | 08/10/1993 |
| K915772 | HOME DIAGNOSTICS, INC. | DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP | 04/14/1992 |
| 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 |
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