FDA 510(k) Applications for Medical Device Product Code "LFR"
(Glucose Dehydrogenase, Glucose)

FDA 510(k) Number Applicant Device Name Decision Date
K994433 ABBOTT DIABETES CARE INC. CONNECT DATA MANAGEMENT SYSTEM 05/05/2000
K992684 ABBOTT DIABETES CARE INC. FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM 01/14/2000
K000582 ABBOTT DIABETES CARE INC. FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 12/05/2000
K083223 ABBOTT DIABETES CARE INC. RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 04/16/2009
K070984 ABBOTT DIABETES CARE INC. THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS 11/01/2007
K111874 ABBOTT LABORATORIES FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS 02/16/2012
K022941 ABBOTT LABORATORIES MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING 10/28/2002
K021960 ABBOTT LABORATORIES PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY 08/16/2002
K001993 ABBOTT LABORATORIES SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS 11/13/2000
K152328 ABOTT LABORATORIES FreeStyle InsuLinx Blood Glucose Monotioring System 09/17/2015
K111268 BAYER HEALTHCARE CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM 03/06/2012
K110894 BAYER HEALTHCARE CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER 03/28/2012
K121190 BAYER HEALTHCARE LLC CONTOUR NEXT BLOOD GLUCOSE METER 07/26/2012
K110587 BAYER HEALTHCARE, LLC CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) 03/28/2012
K982079 BOEHRINGER MANNHEIM CORP. ACCU-CHECK VOICEMATE 08/28/1998
K954833 BOEHRINGER MANNHEIM CORP. ACCU-CHEK ADVANTAGE TEST STRIPS 02/15/1996
K982089 BOEHRINGER MANNHEIM CORP. ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS 09/03/1998
K982002 BOEHRINGER MANNHEIM CORP. ACCU-CHEK COMFORT CURVE TEST STRIP 09/02/1998
K980731 BOEHRINGER MANNHEIM CORP. ACCU-CHEK COMFORT CURVE TEST STRIPS 05/22/1998
K983047 BOEHRINGER MANNHEIM CORP. ACCU-CHEK HQ SYSTEM 02/05/1999
K973662 BOEHRINGER MANNHEIM CORP. ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS 12/15/1997
K951887 BOEHRINGER MANNHEIM CORP. ADVANTAGE TEST STRIPS 08/24/1995
K972876 BOEHRINGER MANNHEIM CORP. GLUCOTREND BASIC SYSTEM 10/09/1997
K131727 CERAGEM MEDISYS INC. CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM 02/28/2014
K032076 CHDIAGNOSTICS LLC SENOVA(R) BLOOD GLUCOSE MONITOR 09/30/2003
K110637 CILAG GMBH INTERNATIONAL ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM 09/07/2011
K874708 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008 12/18/1987
K855080 EM DIAGNOSTIC SYSTEMS, INC. EMDS GLUCOSE TEST PACK ITEM 67656/95 02/11/1986
K951750 EMD CHEMICALS INC. GLUCOSE TEST ITEM NUMBER 97375/94 09/06/1995
K821463 EMD CHEMICALS INC. ULTRACHEM GLUC-DH, #65048 06/02/1982
K821469 EMD CHEMICALS INC. ULTRACHEM GLUC-DH, #65048 06/02/1982
K121207 EPS BIO TECHNOLOGY CORP. EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM 05/18/2012
K101037 EPS BIO TECHNOLOGY CORP. EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 05/23/2011
K133537 EPS BIO TECHNOLOGY CORP. EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM 04/28/2014
K112272 EPS BIO TECHNOLOGY CORP. EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM 09/07/2011
K113243 EPS BIO TECHNOLOGY CORP. EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM 03/28/2012
K112901 EPS BIO TECHNOLOGY CORP. EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM 12/23/2011
K781783 GILFORD DIAGNOSTICS BLOOD SUGAR 12/04/1978
K791213 GILFORD DIAGNOSTICS GLUCOSE (GDH) REAGENT 08/10/1979
K813427 HARLECO ULTRACHEM GLUC-DH 12/31/1981
K813042 HARLECO ULTRACHEM GLUC-DH SET, ITEM #65048 11/10/1981
K811202 HARLECO ULTRACHEM GLUC-DH, ITEM NO. 65048 05/27/1981
K821867 HARLECO DIAGNOSTICS ULTRACHEM GLUC-DH 07/06/1982
K060765 HEMOCUE AB HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 09/06/2006
K041230 HEMOCUE, INC. CLINICAL LABORATORY ANALYZING SYSTEM 05/20/2004
K962415 HEMOCUE, INC. HEMOCUE B-GLCOSE SYSTEM 10/15/1996
K961311 HEMOCUE, INC. HEMOCUE B-GLUCOSE SYSTEM 08/23/1996
K113307 HMD BIOMEDICAL, INC. GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM 07/27/2012
K121433 HMD BIOMEDICAL, INC. GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS 02/14/2013
K113314 HMD BIOMEDICAL, INC. PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM 11/09/2012
K870708 KYOTO DAIICHI KAGAKU CO., LTD. GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM 02/02/1988
K122688 NOVA BIOMEDICAL CORPORATION NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR 04/04/2013
K122435 NOVA BIOMEDICAL CORPORATION NOVA ONE BLOOD GLUCOSE MONITOR 12/20/2012
K101299 Roche Diagnostics ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM 09/21/2011
K043474 ROCHE DIAGNOSTICS CORP. ACCU-CHEK AVIVA SYSTEM 04/27/2005
K010362 ROCHE DIAGNOSTICS CORP. ACCU-CHEK COMFORT CURVE TEST STRIP 03/07/2001
K004010 ROCHE DIAGNOSTICS CORP. ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS 04/26/2001
K031755 ROCHE DIAGNOSTICS CORP. ACCU-CHEK COMPACT TEST STRIP 07/03/2003
K000364 ROCHE DIAGNOSTICS CORP. ACCU-CHEK COMPLETE METER 02/23/2000
K040796 ROCHE DIAGNOSTICS CORP. ACCU-CHEK GO SYSTEM 04/22/2004
K003846 ROCHE DIAGNOSTICS CORP. ACCU-CHEK INFORM METER 03/19/2001
K050872 ROCHE DIAGNOSTICS CORP. ACCU-CHEK INTEGRA SYSTEM 05/02/2005
K993829 ROCHE DIAGNOSTICS CORP. ACCU-CHEK SIMPLICITY SYSTEM 12/09/1999
K051592 ROCHE DIAGNOSTICS CORP. MODIFICATION TO ACCU-CHEK GO SYSTEM 09/02/2005
K142089 ROCHE DIAGNOSTICS CORPORATION ACCU-CHEK AVIVA EXPERT SYSTEM 12/17/2014
K131366 ROCHE DIAGNOSTICS OPERATIONS INC ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM 10/11/2013
K092688 TaiDoc Technology Corporation FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM 07/06/2011
K121224 TaiDoc Technology Corporation GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM 09/19/2012
K120042 TaiDoc Technology Corporation TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM 05/22/2012
K113768 TaiDoc Technology Corporation U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM 04/12/2012
K791110 THE DOW CHEMICAL CO. KINETIC DETERMINATION OF UV GLUCOSE 08/03/1979
K771102 THE DOW CHEMICAL CO. UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS 11/22/1977
K860726 TRACE SCIENTIFIC LTD. ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID 04/21/1986


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