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 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 Nov 24, 2004
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
K041427
Arkray, Inc.
Chemistry · 180d
Cleared Oct 28, 2004
BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
K041478
Becton Dickinson
Chemistry · 147d
Cleared Sep 29, 2004
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
K042015
Bayer Healthcare, Diagnostics Division
Chemistry · 64d
Cleared Jan 30, 2004
GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033055
Diamond Diagnostics, Inc.
Chemistry · 123d
Cleared Dec 04, 2003
RANDOX RX DAYTONA
K024014
Randox Laboratories, Ltd.
Chemistry · 365d
Cleared Aug 05, 2003
ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS
K031472
Lifescan, Inc.
Chemistry · 88d
Cleared Mar 03, 2003
ASCENSIA BREEZE BLOOD GLUCOSE METER
K024062
Bayer Corp.
Chemistry · 84d
Cleared Oct 24, 2002
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
K023194
Lifescan, Inc.
Chemistry · 29d
Cleared Oct 09, 2002
BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
K022580
Becton, Dickinson & CO
Chemistry · 65d
Cleared Sep 10, 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
K022158
Instrumentation Laboratory CO
Chemistry · 70d
Cleared Jun 28, 2002
ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
K021943
Lifescan, Inc.
Chemistry · 31d
Cleared Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
K014139
Roche Diagnostics Corp.
Chemistry · 94d
Cleared Dec 21, 2001
WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106
K011953
Wiener Laboratories Saic
Chemistry · 183d
Cleared Nov 20, 2001
BIOSCANNER 2000
K013068
Polymer Technology Systems, Inc.
Chemistry · 145d
Cleared May 18, 2001
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
K011233
Apex BioTechnology Corp.
Chemistry · 25d
Cleared May 07, 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
K010520
Instrumentation Laboratory CO
Chemistry · 74d
Cleared Mar 15, 2001
RANDOX GLUCOSE (GOD/PAP)
K003346
Randox Laboratories, Ltd.
Chemistry · 141d
Cleared Jan 22, 2001
GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
K002621
Apex BioTechnology Corp.
Chemistry · 152d
Cleared Jan 22, 2001
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
K002624
Apex BioTechnology Corp.
Chemistry · 152d