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
25–48 of 401
Cleared Jun 22, 1999
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL
K983344
Dade Behring, Inc.
Chemistry · 272d
Cleared Apr 17, 1996
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
K944459
Boehringer Mannheim Corp.
Chemistry · 583d
Cleared Nov 21, 1995
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
K952875
Boehringer Mannheim Corp.
Chemistry · 155d
Cleared Nov 04, 1994
SIGMA GLUCOSE REAGENT
K933694
Sigma Chemical Co.
Chemistry · 463d
Cleared Sep 08, 1993
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
K930979
Boehringer Mannheim Corp.
Chemistry · 195d
Cleared Oct 14, 1992
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
K923048
Boehringer Mannheim Corp.
Chemistry · 112d
Cleared Oct 13, 1992
ACCUDATA GLUCOSE TEST STATION
K924475
Boehringer Mannheim Corp.
Chemistry · 40d
Cleared Sep 30, 1992
IL TEST GLUCOSE, PN 181633-80
K922532
Instrumentation Laboratory CO
Chemistry · 125d
Cleared Oct 22, 1990
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM
K904292
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Oct 15, 1990
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM
K904168
Boehringer Mannheim Corp.
Chemistry · 34d
Cleared Oct 16, 1989
COBAS READY GLUCOSE REAGENT
K895526
Roche Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Mar 31, 1989
ROCHE CHLORIDE ELECTRODE
K890528
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Dec 09, 1988
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
K883817
Boehringer Mannheim Corp.
Chemistry · 92d
Cleared Jul 12, 1988
TRACER(TM) II BLOOD GLUCOSE SYSTEM
K881908
Boehringer Mannheim Corp.
Chemistry · 67d
Cleared Apr 07, 1987
MODIFICATION OF ACCU-CHEK II
K863481
Boehringer Mannheim Corp.
Chemistry · 210d
Cleared Jan 05, 1987
ABBOTT SPECTRUM GLUCOSE REAGENT
K864224
Abbott Laboratories
Chemistry · 69d
Cleared Dec 08, 1986
TRACKER SYSTEM
K860948
Boehringer Mannheim Corp.
Chemistry · 271d
Cleared Nov 13, 1986
A-GENT(TM) LIQUID GLUCOSE TRINDER
K863948
Abbott Laboratories
Chemistry · 34d
Cleared Sep 16, 1985
QCA ENZYMATIC GLUCOSE
K853656
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 13d
Cleared Aug 01, 1985
ACCU-CHEK II
K851456
Boehringer Mannheim Corp.
Chemistry · 112d
Cleared Mar 05, 1985
GLUCOSE - TRINDER- REAGENT
K850364
Sigma Chemical Co.
Chemistry · 34d
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