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
97–120 of 401
Cleared Dec 17, 1992
ELITE TEST STRIPS GLUCOMETER
K924499
Heraeus Kulzer, Inc.
Chemistry · 104d
Cleared Dec 03, 1992
ONE TOUCH TEST STRIPS
K923544
Lifescan, Inc.
Chemistry · 140d
Cleared Nov 06, 1992
NOVA 12 ANALYZER, MODIFICATION
K924743
Nova Biomedical Corp.
Chemistry · 53d
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 Sep 15, 1992
ONE TOUCH IIB BLOOD GLUCOSE METER
K922888
Lifescan, Inc.
Chemistry · 91d
Cleared Nov 07, 1991
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
K913357
Lifescan, Inc.
Chemistry · 101d
Cleared Dec 26, 1990
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
K904081
Heraeus Kulzer, Inc.
Chemistry · 112d
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 Sep 13, 1990
SYNERMED GLUCOSE REAGENT KIT
K903063
Synermed, Inc.
Chemistry · 66d
Cleared Mar 29, 1990
GLUCOMETER GX BLOOD GLUCOSE METER
K897015
Heraeus Kulzer, Inc.
Chemistry · 100d
Cleared Nov 08, 1989
ONE TOUCH II METER
K895911
Lifescan, Inc.
Chemistry · 29d
Cleared Oct 16, 1989
COBAS READY GLUCOSE REAGENT
K895526
Roche Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Jun 16, 1989
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
K893117
Bayer Corp.
Chemistry · 52d
Cleared Jun 12, 1989
NEOCHROME(R) III GLUCOSE
K892002
American Monitor Corp.
Chemistry · 76d
Cleared Apr 04, 1989
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873
Heraeus Kulzer, Inc.
Chemistry · 42d
Cleared Mar 31, 1989
ROCHE CHLORIDE ELECTRODE
K890528
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Feb 02, 1989
GLUCOSE-SUPER FAST 4983050 AND 4983500
K882262
American Research Products Co.
Chemistry · 247d
Cleared Jan 13, 1989
CLINISTAT GLUCOSE REAGENT TEST
K884756
Heraeus Kulzer, Inc.
Chemistry · 60d
Cleared Jan 03, 1989
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L
K884909
American Research Products Co.
Chemistry · 41d
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