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
25–48 of 401
Cleared Jan 26, 2012
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
K113208
Apex BioTechnology Corp.
Chemistry · 86d
Cleared Oct 06, 2011
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
K111371
ACON Laboratories, Inc.
Chemistry · 143d
Cleared Aug 31, 2011
MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
K101204
Apex BioTechnology Corp.
Chemistry · 488d
Cleared Apr 27, 2011
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
K103842
Beckman Coulter, Inc.
Chemistry · 118d
Cleared Aug 13, 2010
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
K102037
Apex BioTechnology Corp.
Chemistry · 25d
Cleared Jul 09, 2010
FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
K100405
Taidoc Technology Corporation
Chemistry · 143d
Cleared May 11, 2010
FORA V20 BLOOD GLUCOSE MONITORING SYSTEM
K100406
Taidoc Technology Corporation
Chemistry · 84d
Cleared May 05, 2010
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
K100187
Medica Corp.
Chemistry · 103d
Cleared Apr 01, 2010
CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267
K093506
Taidoc Technology Corporation
Chemistry · 140d
Cleared Mar 26, 2010
CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265
K093941
Taidoc Technology Corporation
Chemistry · 94d
Cleared Nov 20, 2009
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K091814
Taidoc Technology Corporation
Chemistry · 155d
Cleared Apr 09, 2009
AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
K090043
Apex BioTechnology Corp.
Chemistry · 92d
Cleared Mar 11, 2009
U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM
K083570
Taidoc Technology Corporation
Chemistry · 98d
Cleared Jan 30, 2009
FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254
K082482
Taidoc Technology Corporation
Chemistry · 155d
Cleared Jan 09, 2009
FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
K083664
Taidoc Technology Corporation
Chemistry · 30d
Cleared Jul 25, 2008
FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K081714
Taidoc Technology Corporation
Chemistry · 37d
Cleared Jul 02, 2008
CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237
K081609
Taidoc Technology Corporation
Chemistry · 23d
Cleared Apr 10, 2008
GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1
K073648
Apex BioTechnology Corp.
Chemistry · 106d
Cleared Aug 30, 2007
EASYRA CLINICAL CHEMISTRY ANALYZER
K070057
Medica Corp.
Chemistry · 237d
Cleared Jul 11, 2007
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
K070960
Nova Biomedical Corp.
Chemistry · 97d
Cleared Feb 06, 2007
GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM
K062799
Apex BioTechnology Corp.
Chemistry · 140d
Cleared Jan 24, 2007
NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
K063821
Nova Biomedical Corp.
Chemistry · 29d
Cleared Sep 22, 2006
SELFCHECK GLUCO
K061528
Card Guard Scientific Survival , Ltd.
Chemistry · 112d
Cleared Apr 28, 2006
NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
K060345
Nova Biomedical Corp.
Chemistry · 77d