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
145–168 of 401
Cleared Sep 07, 1984
DIATROL BLOOD GLUCOSE TEST SYS
K842684
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 59d
Cleared Aug 27, 1984
SYSTEMATE GLUCOSE 67215
K843151
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 16, 1984
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Jul 19, 1984
GLUCOSE-TRINDER-ADDAY KIT
K842506
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Jun 26, 1984
WAKO B.G. PRETEST STRIPS
K842207
Healthdyne, Inc.
Chemistry · 22d
Cleared Jun 22, 1984
REFLOCHECK-S
K840962
Boehringer Mannheim Corp.
Chemistry · 108d
Cleared May 01, 1984
GLUCOSE ENZYMATIC REAGENT SET
K841055
Medical Specialties, Inc.
Chemistry · 50d
Cleared Feb 13, 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271
Boehringer Mannheim Corp.
Chemistry · 67d
Cleared Dec 08, 1983
WAKO GLUCOSE C
K833257
Wako Chemicals USA, Inc.
Chemistry · 79d
Cleared Nov 07, 1983
TDX GLUCOSE
K833069
Abbott Laboratories
Toxicology · 60d
Cleared Aug 16, 1983
UNITIZED ENZYMATIC GLUCOSE TEST SET
K832159
Stanbio Laboratory
Chemistry · 42d
Cleared Aug 08, 1983
VISIDEX II REAGENT STRIPS
K831989
Miles Laboratories, Inc.
Toxicology · 48d
Cleared Jul 06, 1983
GLUCOSE OXIDASE/PEROXIDASE TEST
K831411
King Diagnostics, Inc.
Microbiology · 65d
Cleared Nov 05, 1982
GLUCOSCAN METER MODEL II
K822699
Lifescan, Inc.
Chemistry · 59d
Cleared Nov 05, 1982
LANCER MSH GLUCOSE DIAG. KIT
K822958
Sherwood Medical Co.
Chemistry · 31d
Cleared Sep 30, 1982
GLUCOSCAN TEST STRIPS
K822697
Lifescan, Inc.
Chemistry · 23d
Cleared May 21, 1982
ACCUDEX REAGENT STRIPS
K821247
Miles Laboratories, Inc.
Chemistry · 22d
Cleared May 14, 1982
VISIDEX REAGENT STRIPS
K821179
Miles Laboratories, Inc.
Chemistry · 17d
Cleared Dec 22, 1981
ELECTROLYTE GEL
K813370
Hi Chem, Inc.
Chemistry · 22d
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