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
49–72 of 401
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 Mar 16, 2011
IVD-GE02
K101947
Sphere Medical , Ltd.
Chemistry · 247d
Cleared Feb 08, 2011
I-STAT 1 WIRELESS ANALYZER
K103195
Abbott Point of Care, Inc.
Chemistry · 102d
Cleared Jan 25, 2011
DIATRON PICTUS 400
K101741
Diatron Group
Chemistry · 217d
Cleared Dec 15, 2010
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
K100525
Seppim S.A.S.
Chemistry · 294d
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 Mar 10, 2010
INTEGRATED LABORATORY AUTOMATION SOLUTION
K091975
Integrated Laboratory Automation Solutions, Inc.
Chemistry · 252d
Cleared Dec 07, 2009
DS-A BLOOD GLUCOSE MONITORING SYSTEM
K082965
Alliance International Co., Ltd.
Chemistry · 430d
Cleared Nov 24, 2009
ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
K092104
Arkray Factory USA, Inc.
Chemistry · 133d
Cleared Nov 20, 2009
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K091814
Taidoc Technology Corporation
Chemistry · 155d
Cleared Oct 23, 2009
ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
K091102
Arkray Factory USA, Inc.
Chemistry · 190d
Cleared Jun 24, 2009
BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
K090109
Epocal, Inc.
Chemistry · 160d
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 Feb 13, 2009
DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
K080636
Hubdic Co., Ltd.
Chemistry · 344d
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 Oct 21, 2008
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
K082417
Arkray Factory USA, Inc.
Chemistry · 60d
Cleared Sep 17, 2008
EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
K082121
Eps Bio Technology Corp.
Chemistry · 51d