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 |
|---|---|---|---|
| May 23, 1986 | K861653 | GLUCOSE HK PROCEDURE Data Medical Associates, Inc. | CGA |
| Apr 24, 1986 | K861204 | GLUCOSE OXIDASE PROCEDURE Data Medical Associates, Inc. | CGA |
| Jan 14, 1986 | K855194 | GLUCOSE OXIDASE REAGENT SET Technostics Intl. | CGA |
| Nov 25, 1985 | K854177 | IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE Clinical Data, Inc. | CGA |
| Nov 22, 1985 | K854335 | GLUCOSE REAGENT SET (GOD/TRINDER) Sterling Diagnostics, Inc. | CGA |
| Nov 19, 1985 | K854260 | CHEMPRO 1000 Sen Tech Medical Corp. | CGA |
| Oct 3, 1985 | K851822 | BETA SCAN TRENDS METER Orange Medical Instruments, Inc. | CGA |
| Sep 16, 1985 | K853656 | QCA ENZYMATIC GLUCOSE Bd Becton Dickinson Vacutainer Systems Preanalytic | CGA |
| Aug 23, 1985 | K851703 | GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT Miles Laboratories, Inc. | CGA |
| Aug 6, 1985 | K851618 | DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS Home Diagnostics, Inc. | CGA |
| Aug 1, 1985 | K851456 | ACCU-CHEK II Boehringer Mannheim Corp. | CGA |
| Jun 10, 1985 | K852130 | GLUCOSE(TRINDER) REAGENT Sigma Diagnostics, Inc. | CGA |
| May 29, 1985 | K851992 | GLU(GOD) REAGENT Alpkem Corp. | CGA |
| Mar 5, 1985 | K850364 | GLUCOSE - TRINDER- REAGENT Sigma Chemical Co. | CGA |
| Mar 5, 1985 | K850257 | BCS GLUCOSE COLORIMETRIC TEST Bioclinical Systems, Inc. | CGA |
| Sep 28, 1984 | K843528 | GLUCOSE OXIDASE ENZYMATIC REAGENT SET Livonia Diagnostics, Inc. | CGA |
| Sep 28, 1984 | K843003 | GLUCOSE AUTO& STAT GA-1120 Kyoto Diagnostics, Inc. | CGA |
| Sep 7, 1984 | K842684 | DIATROL BLOOD GLUCOSE TEST SYS Bd Becton Dickinson Vacutainer Systems Preanalytic | CGA |
| Aug 27, 1984 | K843151 | SYSTEMATE GLUCOSE 67215 Em Diagnostic Systems, Inc. | CGA |
| Aug 23, 1984 | K841369 | BETA SCAN DRYSTIX Orange Medical Instruments, Inc. | CGA |
| Aug 16, 1984 | K842393 | BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE Boehringer Mannheim Corp. | CGA |
| Jul 19, 1984 | K842506 | GLUCOSE-TRINDER-ADDAY KIT Diagnostic Chemicals, Ltd. (Usa) | CGA |
| Jul 12, 1984 | K842221 | WAKO GLUCOSE C Wako Pure Chemical Industries, Ltd. | CGA |
| Jun 26, 1984 | K842207 | WAKO B.G. PRETEST STRIPS Healthdyne, Inc. | CGA |
| Jun 22, 1984 | K840962 | REFLOCHECK-S Boehringer Mannheim Corp. | CGA |
| Jun 22, 1984 | K840484 | DIATRON EASYTEST BLOOD GLUCOSE MONI Medivix, Inc. | CGA |
| May 1, 1984 | K841055 | GLUCOSE ENZYMATIC REAGENT SET Medical Specialties, Inc. | CGA |
| Feb 13, 1984 | K834271 | REFLOCHECK & GLUCOSE TEST STRIP SYS Boehringer Mannheim Corp. | CGA |
| Dec 8, 1983 | K833257 | WAKO GLUCOSE C Wako Chemicals USA, Inc. | CGA |
| Nov 14, 1983 | K832691 | BETA SCAN REAGENT STRIP Orange Medical Instruments, Inc. | CGA |
| Nov 7, 1983 | K833069 | TDX GLUCOSE Abbott Laboratories | CGA |
| Oct 31, 1983 | K831194 | GLUCOKEY Ulster Scientific, Inc. | CGA |
| Oct 28, 1983 | K832926 | ENZYMATIC GLUCOSE DETERMINATION Seragen Diagnostics, Inc. | CGA |
| Aug 16, 1983 | K832159 | UNITIZED ENZYMATIC GLUCOSE TEST SET Stanbio Laboratory | CGA |
| Aug 8, 1983 | K831989 | VISIDEX II REAGENT STRIPS Miles Laboratories, Inc. | CGA |
| Jul 19, 1983 | K831634 | GLUCOSE REAGENT B6360-11 American Scientific Products | CGA |
| Jul 6, 1983 | K831624 | GLUCOSE REAGENT KITS-B6370-10A American Scientific Products | CGA |
| Jul 6, 1983 | K831411 | GLUCOSE OXIDASE/PEROXIDASE TEST King Diagnostics, Inc. | CGA |
| Dec 30, 1982 | K823474 | ENZYMATIC GLUCOSE DETERMINATION The Dow Chemical Co. | CGA |
| Nov 16, 1982 | K822976 | HYPOCOUNT A Pharmaquest Corp. | CGA |
| Nov 5, 1982 | K822958 | LANCER MSH GLUCOSE DIAG. KIT Sherwood Medical Co. | CGA |
| Nov 5, 1982 | K822699 | GLUCOSCAN METER MODEL II Lifescan, Inc. | CGA |
| Nov 5, 1982 | K822486 | HOME BLOOD GLUCOSE MONITOR Pharmaquest Corp. | CGA |
| Sep 30, 1982 | K822697 | GLUCOSCAN TEST STRIPS Lifescan, Inc. | CGA |
| Jul 22, 1982 | K821204 | GLUCOSE(ENZYMATIC) REAGENT SET Omega Medical Electronics | CGA |
| Jun 14, 1982 | K821192 | YSI #24 & 24M GLUCOSE ANALYZERS Yellow Springs Instrument Co., Inc. | CGA |
| May 21, 1982 | K821247 | ACCUDEX REAGENT STRIPS Miles Laboratories, Inc. | CGA |
| May 14, 1982 | K821179 | VISIDEX REAGENT STRIPS Miles Laboratories, Inc. | CGA |
| May 14, 1982 | K821091 | ACCUCHEK BG. Biodynamics Corp. | CGA |
| Mar 11, 1982 | K820465 | CHEMSTRIP UG Biodynamics Corp. | CGA |
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