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
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
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
K150281 NOVA BIOMEDICAL CORPORATION StatStrip Glucose Hospital Meter 05/06/2015
K132121 NOVA BIOMEDICAL CORPORATION STATSTRIP GLUCOSE HOSPITAL METER SYSTEM 09/24/2014
K163490 Nova Biomedical Corporation StatStrip Xpress 2 Glucose Hospital Meter System 01/06/2017
K152986 NOVA BIOMEDICAL CORPORATION StatStrip Xpress 2 Glucose Hospital Meter System 01/27/2016
K161856 Nova Biomedical Corporation StatStrip Xpress Glucose Hospital Meter System 11/15/2016
K150461 NOVA BIOMEDICAL CORPORATION StatStrip Xpress Glucose Hospital Meter System 05/20/2015
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
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
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
K000583 SELFCARE, INC. FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM 03/17/2000
K990939 SELFCARE, INC. FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM 04/20/1999
K993632 SELFCARE, INC. FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM 11/12/1999
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


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