CGA · Class II · 21 CFR 862.1345

FDA Product Code CGA: Glucose Oxidase, Glucose

Leading manufacturers include Lifescan, Inc., Boehringer Mannheim Corp. and Apex BioTechnology Corp..

401
Total
401
Cleared
129d
Avg days
1976
Since
401 devices
265–288 of 401
Cleared Dec 17, 1981
ASTRA REAGENT CONCENTRATE SYSTEM
K812866
Nobel Scientific Industries, Inc.
Chemistry · 65d
Cleared Dec 03, 1981
LIQUIZYME GLUCOSE REAGENT
K813168
American Research Products Co.
Chemistry · 17d
Cleared Aug 31, 1981
ACR ENZYMATIC GLUCOSE OXIDASE
K812258
Harleco
Chemistry · 19d
Cleared Jul 23, 1981
KING DIAGNOSTICS GLUCOSE TEST
K811882
King Diagnostics, Inc.
Chemistry · 22d
Cleared Jul 01, 1981
LIQUIZYME SINGLE SOLUTION GLUCOSE REAG
K811592
Amresco, Inc.
Chemistry · 23d
Cleared May 29, 1981
AMES SERA-PAK GLUCOSE REAGENT
K811392
Miles Laboratories, Inc.
Chemistry · 11d
Cleared Apr 29, 1981
GLUCOSCAN TEST STRIPS
K810993
Lifescan, Inc.
Chemistry · 16d
Cleared Apr 29, 1981
GLUCOSE REAGENT-ENZYMATIC-COLOR 500
K811074
Reagents Applications, Inc.
Chemistry · 9d
Cleared Mar 31, 1981
SERALYZER SYSTEM
K810639
Miles Laboratories, Inc.
Chemistry · 21d
Cleared Mar 31, 1981
GLUCOSE OXIDASE
K810674
Pointe Scientific, Inc.,
Toxicology · 19d
Cleared Aug 27, 1980
GLUCOSE (TRINDER) REAGENT
K801600
Gilford Diagnostics
Chemistry · 44d
Cleared Aug 20, 1980
SERALYZER GLUCOSE REAGENT STRIPS
K801663
Miles Laboratories, Inc.
Chemistry · 30d
Cleared May 28, 1980
REAGENT FOR DETERM. GLUCOSE IN H/SERUM
K800687
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 23, 1980
LANCER GLUCOSE RATE REAGENT KIT
K801071
Sherwood Medical Industries
Chemistry · 17d
Cleared Apr 04, 1980
GLUCOSE OXIDASE REAGENT
K800589
Nobel Scientific Industries, Inc.
Chemistry · 18d
Cleared Feb 21, 1980
LINEAR ENZYMATIC GLUCOSE SYSTEM
K800200
Simmler, Inc.
Chemistry · 22d
Cleared Feb 05, 1980
GLUCOSE OXIDASE REAGENT KIT
K800070
Fisher Scientific Co., LLC
Chemistry · 25d
Cleared Jan 16, 1980
NEOCHROME II GLUCOSE, #4044
K792534
American Monitor Corp.
Chemistry · 40d
Cleared Dec 07, 1979
ELVI GLUCOSE
K792398
Volu Sol Medical Industries
Chemistry · 11d
Cleared Oct 17, 1979
TECHNICON C202 SYSTEM
K791989
Technicon Instruments Corp.
Chemistry · 14d
Cleared Sep 24, 1979
GLUCOSE OXIDASE REAGENT SET
K791669
Macomb Chemical Co.
Chemistry · 27d
Cleared Sep 17, 1979
GLUCOSE REAGENT
K791685
Hi Chem, Inc.
Chemistry · 48d
Cleared Aug 14, 1978
STATTEK-GLUCOSE LOW LEVEL
K781075
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared Jun 19, 1978
BIOSTATOR GLUCOSE ANALYZER
K780393
Miles Laboratories, Inc.
Hematology · 101d