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 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 Sep 17, 2008
EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
K082121
Eps Bio Technology Corp.
Chemistry · 51d
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 Jan 12, 2007
EASYGLUCO, MODEL IGM-0002 G2
K061431
U. S. Diagnostics, Inc.
Chemistry · 233d
Cleared Sep 22, 2006
SELFCHECK GLUCO
K061528
Card Guard Scientific Survival , Ltd.
Chemistry · 112d
Cleared Sep 19, 2006
EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
K061992
Eps Bio Technology Corp.
Chemistry · 68d
Cleared Apr 28, 2006
NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
K060345
Nova Biomedical Corp.
Chemistry · 77d
Cleared Oct 21, 2005
GEM PREMIER 3000
K052121
Instrumentation Laboratory CO
Chemistry · 77d
Cleared Aug 09, 2005
Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM
K050182
Biomedix, Inc.
Chemistry · 194d