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

Glucose Dehydrogenase, Glucose

Regulation 862.1345

0510(k)s in 12 months (73 all time)
0recalls in 12 months (51 all time)
43recalls that name a 510(k)
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Top companies in LFR

Company510(k)sRecalls
Roche Diagnostics1237
Boehringer Mannheim Corp.90
Bayer Healthcare44
Abbott Diabetes Care, Inc.52
Eps Bio Technology Corp.60
Roche Diabetes Care, Inc.05
Abbott Laboratories40
Hemocue AB40
Taidoc Technology Corporation40
Emd Chemicals, Inc.30
Decided510(k)Device and applicantCode
Sep 17, 2015K152328FreeStyle InsuLinx Blood Glucose Monotioring System
Abott Laboratories
LFR
Dec 17, 2014K142089ACCU-CHEK AVIVA EXPERT SYSTEM
Roche Diagnostics Corporation
LFR
Apr 28, 2014K133537EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
Eps Bio Technology Corp., TW
LFR
Feb 28, 2014K131727CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
Ceragem Medisys, Inc., KR
LFR
Oct 11, 2013K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
Roche Diagnostics Operations, Inc.
LFR
Apr 4, 2013K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
Nova Biomedical Corporation
LFR
Feb 14, 2013K121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
Hmd Biomedical, Inc., TW
LFR
Dec 20, 2012K122435NOVA ONE BLOOD GLUCOSE MONITOR
Nova Biomedical Corporation
LFR
Nov 9, 2012K113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
Hmd Biomedical, Inc., TW
LFR
Sep 19, 2012K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
LFR
Jul 27, 2012K113307GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
Hmd Biomedical, Inc., TW
LFR
Jul 26, 2012K121190CONTOUR NEXT BLOOD GLUCOSE METER
Bayer Healthcare, LLC
LFR
May 22, 2012K120042TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
LFR
May 18, 2012K121207EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
Eps Bio Technology Corp., TW
LFR
Apr 12, 2012K113768U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
LFR
Mar 28, 2012K113243EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
Eps Bio Technology Corp., TW
LFR
Mar 28, 2012K110894CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
Bayer Healthcare
LFR
Mar 28, 2012K110587CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
Bayer Healthcare, LLC
LFR
Mar 6, 2012K111268CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
Bayer Healthcare
LFR
Feb 16, 2012K111874FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
Abbott Laboratories
LFR
Dec 23, 2011K112901EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
Eps Bio Technology Corp., TW
LFR
Sep 21, 2011K101299ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
Roche Diagnostics
LFR
Sep 7, 2011K112272EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
Eps Bio Technology Corp., TW
LFR
Sep 7, 2011K110637ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
Cilag GmbH International, CH
LFR
Jul 6, 2011K092688FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
LFR
May 23, 2011K101037EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
Eps Bio Technology Corp., TW
LFR
Apr 16, 2009K083223RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
Abbott Diabetes Care, Inc.
LFR
Nov 1, 2007K070984THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
Abbott Diabetes Care, Inc.
LFR
Sep 6, 2006K060765HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712
Hemocue AB
LFR
Sep 2, 2005K051592MODIFICATION TO ACCU-CHEK GO SYSTEM
Roche Diagnostics Corp.
LFR
May 2, 2005K050872ACCU-CHEK INTEGRA SYSTEM
Roche Diagnostics Corp.
LFR
Apr 27, 2005K043474ACCU-CHEK AVIVA SYSTEM
Roche Diagnostics Corp.
LFR
May 20, 2004K041230CLINICAL LABORATORY ANALYZING SYSTEM
Hemocue, Inc.
LFR
Apr 22, 2004K040796ACCU-CHEK GO SYSTEM
Roche Diagnostics Corp.
LFR
Sep 30, 2003K032076SENOVA(R) BLOOD GLUCOSE MONITOR
Chdiagnostics, LLC
LFR
Jul 3, 2003K031755ACCU-CHEK COMPACT TEST STRIP
Roche Diagnostics Corp.
LFR
Oct 28, 2002K022941MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
Abbott Laboratories
LFR
Aug 16, 2002K021960PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
Abbott Laboratories
LFR
Apr 26, 2001K004010ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
Roche Diagnostics Corp.
LFR
Mar 19, 2001K003846ACCU-CHEK INFORM METER
Roche Diagnostics Corp.
LFR
Mar 7, 2001K010362ACCU-CHEK COMFORT CURVE TEST STRIP
Roche Diagnostics Corp.
LFR
Dec 5, 2000K000582FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
Abbott Diabetes Care, Inc.
LFR
Nov 13, 2000K001993SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
Abbott Laboratories
LFR
May 5, 2000K994433CONNECT DATA MANAGEMENT SYSTEM
Abbott Diabetes Care, Inc.
LFR
Feb 23, 2000K000364ACCU-CHEK COMPLETE METER
Roche Diagnostics Corp.
LFR
Jan 14, 2000K992684FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
Abbott Diabetes Care, Inc.
LFR
Dec 9, 1999K993829ACCU-CHEK SIMPLICITY SYSTEM
Roche Diagnostics Corp.
LFR
Feb 5, 1999K983047ACCU-CHEK HQ SYSTEM
Boehringer Mannheim Corp.
LFR
Sep 3, 1998K982089ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
Boehringer Mannheim Corp.
LFR
Sep 2, 1998K982002ACCU-CHEK COMFORT CURVE TEST STRIP
Boehringer Mannheim Corp.
LFR

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