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
73–96 of 401
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 Jun 13, 2008
ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM
K073416
Arkray Factory USA, Inc.
Chemistry · 193d
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 13, 2007
TRILOGY ANALYZER
K070704
Drew Scientific, Inc.
Chemistry · 122d
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 22, 2007
EUKARE
K062892
Eumed Biotechnology Co., Ltd.
Chemistry · 118d
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 Mar 28, 2006
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
K053079
Hypoguard USA, Inc.
Chemistry · 146d
Cleared Mar 09, 2006
ACCUREX GLUCOSE TEST STRIP
K052207
Incline Medical, LLC
Chemistry · 209d
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
Cleared Aug 02, 2005
GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM
K051285
Infopia Co, Ltd.
Chemistry · 77d
Cleared May 20, 2005
ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K043197
Lifescan, Inc.
Chemistry · 183d
Cleared Apr 29, 2005
EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
K043245
Eps Bio Technology Corp.
Chemistry · 157d
Cleared Apr 08, 2005
EASYGLUCO IGM-0002 G2
K043512
American Healthcare, Inc.
Chemistry · 109d
Cleared Mar 25, 2005
ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
K041881
Hypoguard USA, Inc.
Chemistry · 256d
Cleared Dec 27, 2004
GLUCOSE OXIDASE, GLUCOSE
K040974
Genchem, Inc.
Chemistry · 257d