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 |
|---|---|---|---|
| Dec 7, 1993 | K931196 | APEC GLUCOSE ANALYZER Apec, Inc. | CGA |
| Nov 10, 1993 | K926362 | GLUCOSTIX REAGENT STRIPS Heraeus Kulzer, Inc. | CGA |
| Nov 9, 1993 | K932727 | CHOLESTECH L.D.X. SYSTEM Cholestech Corp. | CGA |
| Sep 8, 1993 | K930979 | ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM Boehringer Mannheim Corp. | CGA |
| Sep 8, 1993 | K926360 | GLUCOFILM TEST STRIPS Heraeus Kulzer, Inc. | CGA |
| Aug 10, 1993 | K922137 | DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP Home Diagnostics, Inc. | CGA |
| Aug 10, 1993 | K922136 | ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP Home Diagnostics, Inc. | CGA |
| Jun 25, 1993 | K931310 | GLUCOMETER M+ BLOOD GLUCOSE METER Heraeus Kulzer, Inc. | CGA |
| Jun 15, 1993 | K922207 | TES-TAPE Lilly Research Laboratories | CGA |
| May 26, 1993 | K931188 | CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC Cascade Medical, Inc. | CGA |
| Apr 20, 1993 | K925551 | HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 Hichem Diagnostics | CGA |
| Dec 28, 1992 | K923587 | GLUCOSE TEST SYSTEM Polymer Technology Corp. | CGA |
| Dec 23, 1992 | K924398 | UNI-CHECK REAGENT STRIP Diagnostic Solutions, Inc. | CGA |
| Dec 17, 1992 | K924499 | ELITE TEST STRIPS GLUCOMETER Heraeus Kulzer, Inc. | CGA |
| Dec 3, 1992 | K923544 | ONE TOUCH TEST STRIPS Lifescan, Inc. | CGA |
| Nov 6, 1992 | K924743 | NOVA 12 ANALYZER, MODIFICATION Nova Biomedical Corp. | CGA |
| Oct 14, 1992 | K923048 | ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM Boehringer Mannheim Corp. | CGA |
| Oct 13, 1992 | K924475 | ACCUDATA GLUCOSE TEST STATION Boehringer Mannheim Corp. | CGA |
| Sep 30, 1992 | K922532 | IL TEST GLUCOSE, PN 181633-80 Instrumentation Laboratory CO | CGA |
| Sep 23, 1992 | K922035 | GLUCOSE 3 Caro Med, Inc. | CGA |
| Sep 15, 1992 | K922888 | ONE TOUCH IIB BLOOD GLUCOSE METER Lifescan, Inc. | CGA |
| Aug 18, 1992 | K921825 | QUICK-CHECK II REAGENT STRIP Diagnostic Solutions, Inc. | CGA |
| Apr 14, 1992 | K915772 | DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP Home Diagnostics, Inc. | CGA |
| Apr 14, 1992 | K915770 | ULTRA+ BLOOD GLUCOSE TEST STRIP Home Diagnostics, Inc. | CGA |
| Mar 4, 1992 | K912580 | FIRST CHOICE Polymer Technology Corp. | CGA |
| Jan 27, 1992 | K914159 | GLUCOSE REAGENT SET Tech Intl. Co. | CGA |
| Nov 7, 1991 | K913357 | ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST Lifescan, Inc. | CGA |
| Oct 2, 1991 | K913806 | YSI MODEL 2300 STAT PLUS Ysis, Inc. | CGA |
| Sep 10, 1991 | K912732 | FIRST CHOICE(TM) Polymer Technology Corp. | CGA |
| Jul 17, 1991 | K912440 | ULTRA BLOOD GLUCOSE MONITORING SYSTEM Home Diagnostics, Inc. | CGA |
| Jul 17, 1991 | K911624 | VISION BG TEST STRIP British-American Medical, Inc. | CGA |
| May 15, 1991 | K911792 | FIRST CHOICE(TM), MODIFICATION Polymer Technology Corp. | CGA |
| May 15, 1991 | K911596 | VISION BG MONITOR British-American Medical, Inc. | CGA |
| May 8, 1991 | K911141 | HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER Hemocue, Inc. | CGA |
| Apr 12, 1991 | K910633 | YSI MODEL 1500 BLOOD GLUCOSE ANALYZER Yellow Springs Instrument Co., Inc. | CGA |
| Apr 3, 1991 | K910573 | GLUCOSE V Caro Med, Inc. | CGA |
| Mar 29, 1991 | K910692 | BIO SCAN-BG(TM Bio Scan Instrument, Inc. | CGA |
| Dec 26, 1990 | K904082 | CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST Cholestech Corp. | CGA |
| Dec 26, 1990 | K904081 | GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM Heraeus Kulzer, Inc. | CGA |
| Oct 22, 1990 | K904292 | ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM Boehringer Mannheim Corp. | CGA |
| Oct 15, 1990 | K904168 | ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM Boehringer Mannheim Corp. | CGA |
| Oct 15, 1990 | K903191 | QUICK CHECK 3 FILM Quantai Biotronics, Inc. | CGA |
| Sep 13, 1990 | K903063 | SYNERMED GLUCOSE REAGENT KIT Synermed, Inc., CA | CGA |
| Jul 10, 1990 | K901613 | MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM Medisense, Inc. | CGA |
| Mar 29, 1990 | K897015 | GLUCOMETER GX BLOOD GLUCOSE METER Heraeus Kulzer, Inc. | CGA |
| Feb 26, 1990 | K896951 | SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM Medisense, Inc. | CGA |
| Dec 19, 1989 | K896144 | AUTOSCAN, AUTOSTRIP AND AUTOCONTROL Cascade Medical, Inc. | CGA |
| Nov 8, 1989 | K895911 | ONE TOUCH II METER Lifescan, Inc. | CGA |
| Nov 8, 1989 | K893661 | QUANTAI UG REAGENT STRIP Quantai Biotronics, Inc. | CGA |
| Oct 16, 1989 | K895526 | COBAS READY GLUCOSE REAGENT Roche Diagnostic Systems, Inc. | CGA |
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