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
241–264 of 401
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 Oct 31, 1983
GLUCOKEY
K831194
Ulster Scientific, Inc.
Hematology · 202d
Cleared Oct 28, 1983
ENZYMATIC GLUCOSE DETERMINATION
K832926
Seragen Diagnostics, Inc.
Chemistry · 70d
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 19, 1983
GLUCOSE REAGENT B6360-11
K831634
American Scientific Products
Chemistry · 60d
Cleared Jul 06, 1983
GLUCOSE OXIDASE/PEROXIDASE TEST
K831411
King Diagnostics, Inc.
Microbiology · 65d
Cleared Jul 06, 1983
GLUCOSE REAGENT KITS-B6370-10A
K831624
American Scientific Products
Chemistry · 47d
Cleared Dec 30, 1982
ENZYMATIC GLUCOSE DETERMINATION
K823474
The Dow Chemical Co.
Chemistry · 38d
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 Jul 22, 1982
GLUCOSE(ENZYMATIC) REAGENT SET
K821204
Omega Medical Electronics
Chemistry · 86d
Cleared Jun 14, 1982
YSI #24 & 24M GLUCOSE ANALYZERS
K821192
Yellow Springs Instrument Co., Inc.
Chemistry · 48d
Cleared May 21, 1982
ACCUDEX REAGENT STRIPS
K821247
Miles Laboratories, Inc.
Chemistry · 22d
Cleared May 14, 1982
ACCUCHEK BG.
K821091
Biodynamics Corp.
Hematology · 25d
Cleared May 14, 1982
VISIDEX REAGENT STRIPS
K821179
Miles Laboratories, Inc.
Chemistry · 17d
Cleared Mar 11, 1982
CHEMSTRIP UG
K820465
Biodynamics Corp.
Chemistry · 17d
Cleared Dec 22, 1981
ELECTROLYTE GEL
K813370
Hi Chem, Inc.
Chemistry · 22d