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
289–312 of 401
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 Mar 30, 1977
GLUCOSE TRINDER, ENZYMATIC
K770317
Icn Pharmaceuticals, 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
Cleared Dec 13, 1976
GLUCOSE OXIDASE REAGENT SYSTEM
K761181
Nobel Scientific Industries, Inc.
Chemistry · 11d
Cleared Dec 09, 1976
GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE
K761153
Advanced Biomedical Methods, Inc.
Chemistry · 10d
Cleared Dec 09, 1976
GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ
K761154
Advanced Biomedical Methods, Inc.
Chemistry · 10d