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
25–48 of 401
Cleared May 07, 2015
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
K143750
Apex BioTechnology Corp.
Chemistry · 127d
Cleared Oct 02, 2014
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
K142302
Polymer Technology Systems, Inc.
Chemistry · 45d
Cleared Sep 17, 2014
GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
K142336
Arkray Factory, Inc.
Chemistry · 27d
Cleared Sep 08, 2014
IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
K133584
Eoshealth, Inc.
Chemistry · 291d
Cleared Jun 30, 2014
ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
K124021
Arkray Factory, Inc.
Chemistry · 550d
Cleared Mar 06, 2014
AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
K131750
Apex BioTechnology Corp.
Chemistry · 265d
Cleared May 15, 2013
ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
K120615
Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen
Chemistry · 441d
Cleared Mar 08, 2013
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
K113636
Philosys Co., Ltd.
Chemistry · 455d
Cleared Jan 14, 2013
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
K121706
Foracare, Inc.
Chemistry · 220d
Cleared Nov 21, 2012
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
K122110
ACON Laboratories, Inc.
Chemistry · 127d
Cleared Sep 05, 2012
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
K121654
I-Sens, Inc.
Chemistry · 92d
Cleared Aug 21, 2012
CLEVER CHOICE
K120921
Simple Diagnostics, Inc.
Chemistry · 147d
Cleared Jun 05, 2012
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
K120759
I-Sens, Inc.
Chemistry · 84d
Cleared May 08, 2012
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
K113670
Infopia Co, Ltd.
Chemistry · 147d
Cleared Apr 06, 2012
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
K120448
Apex BioTechnology Corp.
Chemistry · 52d
Cleared Mar 28, 2012
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
K113547
Apex BioTechnology Corp.
Chemistry · 118d
Cleared Jan 26, 2012
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
K113208
Apex BioTechnology Corp.
Chemistry · 86d
Cleared Oct 28, 2011
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103278
I-Sens, Inc.
Chemistry · 357d
Cleared Oct 06, 2011
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
K111371
ACON Laboratories, Inc.
Chemistry · 143d
Cleared Sep 16, 2011
EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K111728
Eps Bio Technology Corp.
Chemistry · 88d
Cleared Aug 31, 2011
MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
K101204
Apex BioTechnology Corp.
Chemistry · 488d
Cleared Apr 27, 2011
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
K103842
Beckman Coulter, Inc.
Chemistry · 118d
Cleared Feb 08, 2011
I-STAT 1 WIRELESS ANALYZER
K103195
Abbott Point of Care, Inc.
Chemistry · 102d
Cleared Aug 13, 2010
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
K102037
Apex BioTechnology Corp.
Chemistry · 25d