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 |
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GLUCOKEY |
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UNIDEX, INC. |
UNIDEX GLUCOSE TEST STRIP |
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UNIVERSITY OF WISCONSIN |
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WAKO CHEMICALS, USA, INC. |
WAKO AUTOKIT GLUCOSE |
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WAKO CHEMICALS, USA, INC. |
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12/08/1983 |
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WAKO INTL., INC. |
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WAKO PURE CHEMICAL INDUSTRIES, LTD. |
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WIENER LABORATORIES S.A.I.C. |
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WORTHINGTON BIOCHEMICAL CORP. |
STATZYME GLUCOSE |
07/11/1977 |
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YELLOW SPRINGS INSTRUMENT CO., INC. |
YSI #24 & 24M GLUCOSE ANALYZERS |
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YELLOW SPRINGS INSTRUMENT CO., INC. |
YSI MODEL 1500 BLOOD GLUCOSE ANALYZER |
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YELLOW SPRINGS INSTRUMENT CO., INC. |
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10/02/1991 |