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 Oct 21, 2005
GEM PREMIER 3000
K052121
Instrumentation Laboratory CO
Chemistry · 77d
Cleared May 20, 2005
ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K043197
Lifescan, Inc.
Chemistry · 183d
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 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
Cleared Dec 18, 2000
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
K001441
Lifescan, Inc.
Chemistry · 224d
Cleared Sep 05, 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907
Roche Diagnostics Corp.
Chemistry · 75d
Cleared Feb 23, 2000
ACCU-CHEK ADVANTAGE METER
K000365
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Jul 09, 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS
K990649
Bayer Corp.
Chemistry · 130d
Cleared Jun 30, 1999
GLUCOMETER ELITE TEST STRIPS
K991242
Bayer Corp.
Chemistry · 79d
Cleared Jun 22, 1999
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL
K983344
Dade Behring, Inc.
Chemistry · 272d
Cleared May 21, 1999
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K984261
Lifescan, Inc.
Chemistry · 175d
Cleared Apr 29, 1999
IN TOUCH DIABETES MANAGEMENT SOFTWARE
K984527
Lifescan, Inc.
Chemistry · 129d
Cleared Mar 18, 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER
K984006
Bayer Corp.
Chemistry · 128d