Panels › Clinical Chemistry › Product code CGA · Class 2
Glucose Oxidase, Glucose
Regulation 862.1345
1510(k)s in 12 months (401 all time)
0recalls in 12 months (89 all time)
79recalls that name a 510(k)
Top companies in CGA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 6, 1989 | K893205 | FIRST CHOICE (TM) Polymer Technology Corp. | CGA |
| Aug 3, 1989 | K893404 | INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM Apprise, Inc. | CGA |
| Jul 20, 1989 | K891050 | STAT CHEM SYSTEM Diagnostic Resources, Inc. | CGA |
| Jun 16, 1989 | K893117 | GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST Bayer Corp. | CGA |
| Jun 12, 1989 | K892002 | NEOCHROME(R) III GLUCOSE American Monitor Corp. | CGA |
| May 22, 1989 | K891480 | YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER Yellow Springs Instrument Co., Inc. | CGA |
| Apr 4, 1989 | K890873 | GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3 Heraeus Kulzer, Inc. | CGA |
| Mar 31, 1989 | K890528 | ROCHE CHLORIDE ELECTRODE Roche Diagnostic Systems, Inc. | CGA |
| Mar 15, 1989 | K890524 | APEC GLUCOSE ANALYZER Amdev, Inc. | CGA |
| Feb 27, 1989 | K890336 | GLUCOSE (GOD) REAGENT Alpkem Corp. | CGA |
| Feb 2, 1989 | K882262 | GLUCOSE-SUPER FAST 4983050 AND 4983500 American Research Products Co. | CGA |
| Jan 13, 1989 | K884756 | CLINISTAT GLUCOSE REAGENT TEST Heraeus Kulzer, Inc. | CGA |
| Jan 3, 1989 | K884909 | GLUCOSE LIQUID AMRESCO #4628300 & 4628001L American Research Products Co. | CGA |
| Dec 29, 1988 | K884993 | VISUAL BLOOD GLUCOSE TEST SYSTEM Diagnostic Systems | CGA |
| Dec 9, 1988 | K883817 | ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM Boehringer Mannheim Corp. | CGA |
| Aug 23, 1988 | K875049 | MD STRIPS BG Amatech International, Inc. | CGA |
| Jul 12, 1988 | K881908 | TRACER(TM) II BLOOD GLUCOSE SYSTEM Boehringer Mannheim Corp. | CGA |
| Jul 8, 1988 | K880703 | QUANTAI BG(TM) REAGENT STRIP Quantai Biotronics, Inc. | CGA |
| Apr 18, 1988 | K880585 | DEXPAD, BLOOD GLUCOSE STRIP Mach Diag. C/O Wichita State University | CGA |
| Apr 18, 1988 | K875211 | GLUCOSE (TRINDER) CAT. # 220-32 Diagnostic Chemicals, Ltd. (Usa) | CGA |
| Apr 13, 1988 | K872889 | ROMEO(TM) MODEL 1000 Diva Medical Systems, Inc. | CGA |
| Dec 22, 1987 | K871835 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT Miles Laboratories, Inc. | CGA |
| Oct 23, 1987 | K873128 | GLUCOSE REAGENT KIT A-Kem, Inc. | CGA |
| Oct 20, 1987 | K872505 | DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS Home Diagnostics, Inc. | CGA |
| Sep 16, 1987 | K871586 | GLUCOCHEK S.C. WITH AUDIO OPTION Larken Industries, Inc. | CGA |
| Aug 31, 1987 | K873117 | BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT Biotrol, USA, Inc. | CGA |
| Aug 13, 1987 | K872049 | NOVOCHECK/CHECKPOINT/CONTROL SOLUTION Garid, Inc. | CGA |
| May 26, 1987 | K864282 | GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA Medical Device Consultants, Inc. | CGA |
| May 12, 1987 | K871650 | GLUCOSE ENZYME - COLOR REAGENT SET Biochemical Trade, Inc. | CGA |
| Apr 7, 1987 | K863481 | MODIFICATION OF ACCU-CHEK II Boehringer Mannheim Corp. | CGA |
| Mar 13, 1987 | K870631 | FAST GLUCOSE Sclavo, Inc. | CGA |
| Mar 10, 1987 | K863223 | DIMENSION-WBG Dimension Diagnostics | CGA |
| Mar 6, 1987 | K870616 | GLUCOSE OXIDASE REAGENT Intersect Systems, Inc. | CGA |
| Feb 25, 1987 | K864322 | MPX SYSTEM, GLUCOSE TEST SYSTEM Lifescan, Inc. | CGA |
| Feb 18, 1987 | K864530 | SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. Miles Laboratories, Inc. | CGA |
| Jan 5, 1987 | K864224 | ABBOTT SPECTRUM GLUCOSE REAGENT Abbott Laboratories | CGA |
| Dec 8, 1986 | K863468 | EXACTECH(TM) Travenol Laboratories, S.A. | CGA |
| Dec 8, 1986 | K860948 | TRACKER SYSTEM Boehringer Mannheim Corp. | CGA |
| Dec 4, 1986 | K853733 | MED-PEN/MED-POINT Garid, Inc. | CGA |
| Nov 24, 1986 | K863102 | GLUCOMETER-E J. D. Assoc. | CGA |
| Nov 13, 1986 | K863948 | A-GENT(TM) LIQUID GLUCOSE TRINDER Abbott Laboratories | CGA |
| Nov 13, 1986 | K863926 | GLUCOSE OXIDASE Tech-Co, Inc. | CGA |
| Nov 5, 1986 | K862984 | UNIDEX GLUCOSE TEST STRIP Unidex, Inc. | CGA |
| Sep 3, 1986 | K862721 | ENZYMATIC BLOOD GLUCOSE U. S. Diagnostics, Inc. | CGA |
| Aug 29, 1986 | K860682 | GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET Gambro, Inc. | CGA |
| Aug 4, 1986 | K855178 | DIATRON BLOOD GLUCOSE METER Dextron, Inc. | CGA |
| Aug 4, 1986 | K854329 | DIAGEM 300 BG REAGENT STRIPS Seton Products, Inc. | CGA |
| Jul 2, 1986 | K861303 | GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER Miles Laboratories, Inc. | CGA |
| Jul 2, 1986 | K855202 | GLUCOMETER M BLOOD GULCOSE METER Miles Laboratories, Inc. | CGA |
| Jun 16, 1986 | K852960 | DIRECT University of Wisconsin | CGA |
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