ClearanceBrief
Panels › Clinical Chemistry › Product code CGA · Class 2

Glucose Oxidase, Glucose

Regulation 862.1345

1510(k)s in 12 months (401 all time)
0recalls in 12 months (89 all time)
79recalls that name a 510(k)
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Top companies in CGA

Company510(k)sRecalls
Lifescan, Inc.215
Roche Diagnostics Corp.320
Boehringer Mannheim Corp.170
Apex BioTechnology Corp.140
Abbott Point of Care, Inc.66
Miles Laboratories, Inc.120
Nova Biomedical Corp.75
Instrumentation Laboratory CO92
Medisense, Inc.110
Heraeus Kulzer, Inc.100
Decided510(k)Device and applicantCode
Feb 8, 2011K103195I-STAT 1 WIRELESS ANALYZER
Abbott Point of Care, Inc.
CGA
Jan 25, 2011K101741DIATRON PICTUS 400
Diatron Group
CGA
Dec 15, 2010K100525ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
Seppim S.A.S.
CGA
Aug 13, 2010K102037AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
Apex BioTechnology Corp., TW
CGA
Jul 9, 2010K100405FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
CGA
May 11, 2010K100406FORA V20 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
CGA
May 5, 2010K100187EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
Medica Corp.
CGA
Apr 1, 2010K093506CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267
Taidoc Technology Corporation, TW
CGA
Mar 26, 2010K093941CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265
Taidoc Technology Corporation, TW
CGA
Mar 10, 2010K091975INTEGRATED LABORATORY AUTOMATION SOLUTION
Integrated Laboratory Automation Solutions, Inc.
CGA
Dec 7, 2009K082965DS-A BLOOD GLUCOSE MONITORING SYSTEM
Alliance International Co., Ltd., TW
CGA
Nov 24, 2009K092104ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
Arkray Factory USA, Inc.
CGA
Nov 20, 2009K091814FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE
Taidoc Technology Corporation, TW
CGA
Oct 23, 2009K091102ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
Arkray Factory USA, Inc.
CGA
Jun 24, 2009K090109BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
Epocal, Inc., CA
CGA
Apr 9, 2009K090043AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
Apex BioTechnology Corp., TW
CGA
Mar 11, 2009K083570U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
CGA
Feb 13, 2009K080636DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
Hubdic Co., Ltd.
CGA
Jan 30, 2009K082482FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254
Taidoc Technology Corporation, TW
CGA
Jan 9, 2009K083664FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
Taidoc Technology Corporation, TW
CGA
Oct 21, 2008K082417GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
Arkray Factory USA, Inc.
CGA
Sep 17, 2008K082121EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
Eps Bio Technology Corp., TW
CGA
Jul 25, 2008K081714FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
Taidoc Technology Corporation, TW
CGA
Jul 2, 2008K081609CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237
Taidoc Technology Corporation, TW
CGA
Jun 13, 2008K073416ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM
Arkray Factory USA, Inc.
CGA
Apr 10, 2008K073648GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1
Apex BioTechnology Corp., TW
CGA
Aug 30, 2007K070057EASYRA CLINICAL CHEMISTRY ANALYZER
Medica Corp.
CGA
Jul 13, 2007K070704TRILOGY ANALYZER
Drew Scientific, Inc.
CGA
Jul 11, 2007K070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
Nova Biomedical Corp.
CGA
Feb 6, 2007K062799GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM
Apex BioTechnology Corp.
CGA
Jan 24, 2007K063821NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Nova Biomedical Corp.
CGA
Jan 22, 2007K062892EUKARE
Eumed Biotechnology Co., Ltd., TW
CGA
Jan 12, 2007K061431EASYGLUCO, MODEL IGM-0002 G2
U. S. Diagnostics, Inc.
CGA
Sep 22, 2006K061528SELFCHECK GLUCO
Card Guard Scientific Survival , Ltd., IL
CGA
Sep 19, 2006K061992EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
Eps Bio Technology Corp., TW
CGA
Apr 28, 2006K060345NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
Nova Biomedical Corp.
CGA
Mar 28, 2006K053079ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
Hypoguard USA, Inc.
CGA
Mar 9, 2006K052207ACCUREX GLUCOSE TEST STRIP
Incline Medical, LLC
CGA
Oct 21, 2005K052121GEM PREMIER 3000
Instrumentation Laboratory CO
CGA
Aug 9, 2005K050182Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM
Biomedix, Inc.
CGA
Aug 2, 2005K051285GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM
Infopia Co, Ltd., KR
CGA
May 20, 2005K043197ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
Lifescan, Inc.
CGA
Apr 29, 2005K043245EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
Eps Bio Technology Corp.
CGA
Apr 8, 2005K043512EASYGLUCO IGM-0002 G2
American Healthcare, Inc.
CGA
Mar 25, 2005K041881ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
Hypoguard USA, Inc.
CGA
Dec 27, 2004K040974GLUCOSE OXIDASE, GLUCOSE
Genchem, Inc.
CGA
Nov 24, 2004K041427THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
Arkray, Inc.
CGA
Oct 28, 2004K041478BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
Becton Dickinson
CGA
Sep 29, 2004K042015ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
Bayer Healthcare, Diagnostics Division
CGA
May 21, 2004K033627Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM
Biomedix, Inc.
CGA

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