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
97–120 of 401
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 Dec 16, 1999
AVL OPTI CRITICAL CARE ANALYZER
K993837
Avl Scientific Corp.
Chemistry · 34d
Cleared Nov 23, 1999
HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
K993128
Health Hero Network, Inc.
Chemistry · 64d
Cleared Nov 12, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K993632
Selfcare, Inc.
Immunology · 16d
Cleared Sep 24, 1999
PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
K992988
Home Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 17, 1999
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
K991480
Selfcare, Inc.
Chemistry · 142d
Cleared Sep 08, 1999
GO GLUCOSE MONITORING SYSTEM
K991754
Lxn Corp.
Chemistry · 107d
Cleared Aug 02, 1999
DUET II GLUCOSE CONTROL MONITORING SYSTEM
K990942
Lxn Corp.
Chemistry · 133d
Cleared Jul 09, 1999
PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST
K983504
Medisense, Inc.
Chemistry · 276d
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 Apr 20, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K990939
Selfcare, Inc.
Chemistry · 29d
Cleared Mar 18, 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER
K984006
Bayer Corp.
Chemistry · 128d
Cleared Dec 10, 1998
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM
K982076
Amira Medical, Inc.
Chemistry · 181d
Cleared Dec 08, 1998
PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST
K982303
Medisense, Inc.
Chemistry · 160d
Cleared Jul 30, 1998
SENSOREX BLOOD GLUCOSE MONITORING SYSTEM
K980573
Chronimed, Inc.
Chemistry · 163d
Cleared May 07, 1998
CARESIDE GLUCOSE
K981183
Exigent Diagnostics, Inc.
Chemistry · 36d
Cleared Jan 26, 1998
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K974451
Lifescan, Inc.
Chemistry · 62d
Cleared Jan 22, 1998
MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON
K972669
Polymer Technology Systems, Inc.
Chemistry · 190d