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
169–192 of 401
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 23, 1980
LANCER GLUCOSE RATE REAGENT KIT
K801071
Sherwood Medical Industries
Chemistry · 17d
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 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
Cleared Mar 03, 1978
AUTOZYME GLUCOSE OXIDASE (TRINDER)
K772308
J.T. Baker Chemical Co.
Chemistry · 77d
Cleared Feb 13, 1978
GLUCOSE REAGENT FOR GLUCOSE ANALYZER
K780093
Harleco
Chemistry · 26d
Cleared Oct 18, 1977
GLUCOSE REAGENT FOR GLUC. ANALYZER
K771754
Harleco
Chemistry · 32d
Cleared Sep 12, 1977
MULTISTAT III GLUCOSE TEST
K771471
Instrumentation Laboratory CO
Chemistry · 39d
Cleared Jul 21, 1977
DIAG. OZYRATE GLUCOSE REAG. SET
K771059
J.T. Baker Chemical Co.
Chemistry · 38d
Cleared Jul 15, 1977
TRENDAR
K771000
Hi Chem, Inc.
Chemistry · 42d
Cleared Feb 23, 1977
GO/HPO-GLUCOSE REAGENT (TRINDER)
K770200
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Feb 11, 1977
REFLOMAT/REFLOTEST SYSTEM
K761148
Boehringer Mannheim Corp.
Chemistry · 77d
Cleared Jan 25, 1977
GLUCOSE ANALYZER 2
K761060
Beckman Instruments, Inc.
Chemistry · 68d