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
169–192 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 Aug 18, 1992
QUICK-CHECK II REAGENT STRIP
K921825
Diagnostic Solutions, Inc.
Chemistry · 124d
Cleared Apr 14, 1992
ULTRA+ BLOOD GLUCOSE TEST STRIP
K915770
Home Diagnostics, Inc.
Chemistry · 112d
Cleared Apr 14, 1992
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
K915772
Home Diagnostics, Inc.
Chemistry · 112d
Cleared Mar 04, 1992
FIRST CHOICE
K912580
Polymer Technology Corp.
Chemistry · 266d
Cleared Nov 07, 1991
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
K913357
Lifescan, Inc.
Chemistry · 101d
Cleared Sep 10, 1991
FIRST CHOICE(TM)
K912732
Polymer Technology Corp.
Chemistry · 82d
Cleared Jul 17, 1991
ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K912440
Home Diagnostics, Inc.
Chemistry · 44d
Cleared May 15, 1991
FIRST CHOICE(TM), MODIFICATION
K911792
Polymer Technology Corp.
Chemistry · 23d
Cleared Apr 12, 1991
YSI MODEL 1500 BLOOD GLUCOSE ANALYZER
K910633
Yellow Springs Instrument Co., Inc.
Chemistry · 58d
Cleared Dec 26, 1990
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
K904081
Heraeus Kulzer, Inc.
Chemistry · 112d
Cleared Dec 26, 1990
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
K904082
Cholestech Corp.
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