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
121–144 of 401
Cleared Jan 02, 1998
GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM
K971653
Clinical Diagnostics, Inc.
Chemistry · 241d
Cleared Dec 16, 1997
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
K972473
Lifescan, Inc.
Chemistry · 168d
Cleared Oct 31, 1997
DUET GLUCOSE CONTROL MONITORING SYSTEM
K973140
Lxn Corp.
Chemistry · 71d
Cleared Sep 17, 1997
GLUCOSITE TEST SYSTEM
K971145
Gds Technology, LLC
Chemistry · 173d
Cleared Sep 09, 1997
AVL OMNI ANALYZER
K972733
Avl Scientific Corp.
Chemistry · 50d
Cleared Aug 08, 1997
PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP
K971812
Medisense, Inc.
Chemistry · 84d
Cleared Jun 20, 1997
ELECT II BLOOD GLUCOSE MONITORING SYSTEM
K970707
Selfcare, Inc.
Chemistry · 114d
Cleared May 12, 1997
SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
K970556
Lifescan, Inc.
Chemistry · 88d
Cleared Apr 21, 1997
LIQUID GLUCOSE (OXIDASE) REAGENT SET
K970781
Pointe Scientific, Inc.,
Chemistry · 48d
Cleared Feb 20, 1997
SUPREME II METER
K963544
Chronimed, Inc.
Chemistry · 169d
Cleared Feb 20, 1997
PRECISION G BLOOD GLUCOSE TESTING SYSTEM
K963676
Medisense, Inc.
Chemistry · 160d
Cleared Feb 10, 1997
GLUCOMETER ELITE BLOOD GLUCOSE METER
K964630
Bayer Corp.
Chemistry · 83d
Cleared Jan 21, 1997
GLUCOMETER DEX DIABETES CARE SYSTEM
K963500
Bayer Corp.
Chemistry · 140d
Cleared Jan 17, 1997
SIGMA DIAGNOSTICS GLUCOSE REAGENT
K963535
Sigma Diagnostics, Inc.
Chemistry · 135d
Cleared Nov 07, 1996
PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL
K960855
Home Diagnostics, Inc.
Chemistry · 251d
Cleared Sep 24, 1996
AMD HOME HEALTH MONITORING SYSTEM
K960337
Advanced Medical Devices, Inc.
Chemistry · 244d
Cleared Sep 05, 1996
ELECT BLOOD GLUCOSE MONITORIG SYSTEM
K961985
Selfcare, Inc.
Chemistry · 107d
Cleared Aug 16, 1996
SAFESTRIP
K955107
Firehouse Medical, Inc.
Chemistry · 282d
Cleared Jul 26, 1996
PRECISION QID BLOOD GLUCOSE TEST STRIP
K962295
Medisense, Inc.
Chemistry · 71d
Cleared Jul 23, 1996
CHEMCARD GLUCOSE TEST
K943503
Chem-Elec, Inc.
Chemistry · 734d
Cleared Jun 28, 1996
LXN BLOOD GLUCOSE TEST SYSTEM
K960034
Lxn Corp.
Chemistry · 177d
Cleared Jun 28, 1996
SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM
K960053
Selfcare, Inc.
Chemistry · 176d
Cleared Jun 21, 1996
EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM
K961337
Medisense, Inc.
Chemistry · 74d
Cleared May 17, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
K955286
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 183d