CGA · Class II · 21 CFR 862.1345

FDA Product Code CGA: Glucose Oxidase, Glucose

Leading manufacturers include Boehringer Mannheim Corp., Instrumentation Laboratory CO and Abbott Point of Care, Inc..

401
Total
401
Cleared
129d
Avg days
1976
Since
401 devices
49–72 of 401
Cleared Jun 22, 1984
REFLOCHECK-S
K840962
Boehringer Mannheim Corp.
Chemistry · 108d
Cleared Feb 13, 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271
Boehringer Mannheim Corp.
Chemistry · 67d
Cleared Nov 07, 1983
TDX GLUCOSE
K833069
Abbott Laboratories
Toxicology · 60d
Cleared Aug 14, 1978
STATTEK-GLUCOSE LOW LEVEL
K781075
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared Sep 12, 1977
MULTISTAT III GLUCOSE TEST
K771471
Instrumentation Laboratory CO
Chemistry · 39d
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