FDA 510(k) Applications for Medical Device Product Code "NBW"
(System, Test, Blood Glucose, Over The Counter)

FDA 510(k) Number Applicant Device Name Decision Date
K130094 ABBOTT DIABETES CARE FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM 06/27/2013
K142928 ABBOTT DIABETES CARE INC FreeStyle Precision Neo Blood Glucose Monitoring System 09/30/2015
K062770 ABBOTT DIABETES CARE INC. COPILOT HEALTH MANAGEMENT SYSTEM 12/14/2006
K051839 ABBOTT DIABETES CARE INC. FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 03/09/2006
K050500 ABBOTT DIABETES CARE INC. FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM 06/27/2005
K031260 ABBOTT DIABETES CARE INC. FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 12/19/2003
K092638 ABBOTT DIABETES CARE INC. FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 06/15/2010
K051802 ABBOTT DIABETES CARE INC. FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM 08/09/2005
K120568 ABBOTT DIABETES CARE INC. FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM 03/29/2012
K070850 ABBOTT DIABETES CARE INC. FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM 04/10/2007
K092602 ABBOTT DIABETES CARE INC. FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System 05/14/2010
K171941 Abbott Diabetes Care Inc. FreeStyle Precision Neo Blood Glucose Test Strips 09/27/2017
K140371 ABBOTT DIABETES CARE INC. FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) 09/30/2014
K153330 Abbott Diabetes Care Inc. FreeStyle Precision Neo H Blood Glucose Monitoring System 02/19/2016
K132511 ABBOTT DIABETES CARE INC. FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM 12/24/2013
K020866 ABBOTT DIABETES CARE INC. FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM 06/11/2002
K012014 ABBOTT DIABETES CARE INC. MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM 12/05/2001
K080960 ABBOTT DIABETES CARE INC. PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS 09/05/2008
K081975 ABBOTT DIABETES CARE INC. RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) 11/26/2008
K123089 ABBOTT LABORATORIES FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 04/05/2013
K152442 ABBOTT LABORATORIES Freestyle Freedom Blood Glucose Monitoring Sytem 12/17/2015
K150531 Abbott Laboratories FreeStyle Freedom Lite Blood Glucose Monitoring System 06/05/2015
K150332 ABBOTT LABORATORIES FreeStyle Lite Blood Glucose Monitoring System 06/05/2015
K022182 ABBOTT LABORATORIES MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM 09/09/2002
K040814 ABBOTT LABORATORIES MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM 04/15/2004
K040628 ABBOTT LABORATORIES PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM 03/25/2004
K033845 ABBOTT LABORATORIES PRECISION XCEED DIABETES MONITORING SYSTEM 01/08/2004
K010553 ABBOTT LABORATORIES PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY 06/18/2001
K023256 ABBOTT LABORATORIES PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO 04/23/2003
K012975 ABBOTT LABORATORIES SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS 02/28/2002
K051213 ABBOTT LABORATORIES INC PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS 05/27/2005
K161867 ACON LABORATORIES On Call Pro Blood Glucose Monitoring System 08/05/2016
K090057 ACON LABORATORIES CO. ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM 04/08/2009
K131469 ACON LABORATORIES, INC. ACON ON CALL DIABETES MANAGEMENT SOFTWARE 01/06/2014
K132086 ACON LABORATORIES, INC. ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM 12/19/2013
K180196 ACON Laboratories, Inc. On Call Express Mobile Blood Glucose Monitoring System 03/07/2018
K151595 ACON Laboratories, Inc. On Call Express Pro Blood Glucose Monitoring System 09/05/2015
K101371 ACON LABORATORIES, INC. ON CALL PLUS DIABETES MONITORING SOFTWARE 01/07/2011
K130284 ACON LABORATORIES, INC. ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM 12/20/2013
K123010 ACON LABORATORIES, INC. ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM 12/14/2012
K071393 AGAMATRIX JAZZ BLOOD GLUCOSE MONITORING SYSTEM 07/20/2007
K063409 AGAMATRIX LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 01/12/2007
K072413 AGAMATRIX MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM 09/27/2007
K101597 AGAMATRIX WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 10/18/2010
K073573 AGAMATRIX WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM 01/30/2008
K062434 AGAMATRIX ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 11/13/2006
K132821 AGAMATRIX INC AGAMATRIX HEALTH MANAGER 11/20/2013
K130535 AGAMATRIX INC IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION 04/17/2013
K103544 AGAMATRIX INC IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D 12/07/2011
K083265 AGAMATRIX INC JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 02/03/2009
K052762 AGAMATRIX INC LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 01/23/2006
K152365 AgaMatrix, Inc. AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System 04/21/2016
K161834 AgaMatrix, Inc. One Drop Blood Glucose Monitoring System 11/30/2016
K083628 ALL MEDICUS CO., LTD GLUCODR AUTO SYSTEM 05/01/2009
K082328 ALL MEDICUS CO., LTD GLUCODR PLUS SYSTEM, MODEL AGM-3000 02/27/2009
K050985 ALL MEDICUS CO., LTD GLUCODR SUPERSENSOR SYSTEM 10/07/2005
K130657 ALL MEDICUS CO., LTD LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE 07/15/2013
K170241 All Medicus Co., Ltd. GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System 10/13/2017
K132663 ALLIANCE INTERNATIONAL CO., LTD. I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM 04/20/2015
K102063 ALR TECHNOLOGIES HEALTH-E-CONNECT SYSTEM 10/11/2011
K043543 AMERICAN HEALTHCARE INC. BLOOD GLUCOSE MONITORING SYSTEM 04/08/2005
K031501 AMERICAN HEALTHCARE INC. EASYGLUCO, MODEL IGM0002 10/16/2003
K153561 ANDON HEALTH CO., LTD AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System 02/16/2017
K153286 Andon health Co., Ltd iHealth Align Gluco-Monitoring system 08/19/2016
K170231 Andon health Co., Ltd iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)á 09/15/2017
K133790 ANDON HEALTH CO., LTD IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM 05/22/2014
K153278 Andon Health Co., Ltd Wireless Smart Gluco-Monitoring System 08/19/2016
K073030 ANDON HEALTH CO.,LTD AG-605 BLOOD GLUCOSE MONITORING SYSTEM 07/21/2008
K150833 ANDON HEALTH CO.,LTD iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 12/04/2015
K120813 ANDON MEDICAL CO., LTD BLOOD GLUCOSE MONITORING SYSTEM 12/07/2012
K093262 ANDON MEDICAL CO., LTD. AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM 07/13/2010
K110017 ANDON MEDICAL CO., LTD. AG-608N BLOOD GLUCOSE MONITORING SYSTEM 01/18/2012
K093755 ANDON MEDICAL CO., LTD. AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM 07/15/2011
K112738 ANDON MEDICAL CO., LTD. ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE 09/30/2011
K102678 ANDON MEDICAL CO., LTD. ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS 08/26/2011
K101307 ANDON MEDICAL CO., LTD. BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 08/09/2011
K123935 ANDON MEDICAL CO., LTD. IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM 04/12/2013
K120649 APEX BIO TECHNOLOGY CORP AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM 07/06/2012
K170267 Apex Bio Technology Corp. BGM009 Plus Blood Glucose Monitoring System 03/09/2017
K070088 APEX BIOTECHNOLOGY CORP. ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM 02/16/2007
K102481 APEX BIOTECHNOLOGY CORP. AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP 04/28/2011
K150396 APEX BIOTECHNOLOGY CORP. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 10/14/2015
K113098 APEX BIOTECHNOLOGY CORP. AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III 01/17/2012
K141036 APEX BIOTECHNOLOGY CORP. BGM009 BLOOD GLUCOSE MONITORING SYSTEM 05/01/2015
K161299 APEX BIOTECHNOLOGY CORP. BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System 12/23/2016
K102816 APEX BIOTECHNOLOGY CORP. GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS 09/15/2011
K073137 APEX BIOTECHNOLOGY CORP. GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 04/01/2008
K173658 Applied Biomedical LLC Confidence Blood Glucose Monitoring System 08/21/2018
K142035 ARKRAY FACTORY INC. GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM 09/05/2014
K110709 ARKRAY Factory USA, Inc. ARK CARE DIABETES MANAGMENT SYSTEM 05/19/2011
K093819 ARKRAY Factory USA, Inc. ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) 06/09/2010
K090332 ARKRAY Factory USA, Inc. ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 08/14/2009
K063771 ARKRAY Factory USA, Inc. GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM 08/09/2007
K090653 ARKRAY Factory USA, Inc. POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM 10/09/2009
K170064 ARKRAY FACTORY, INC. GLUCOCARD W Blood Glucose Monitoring System 08/16/2017
K063068 ARKRAY USA, INC. FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 12/20/2006
K160682 ASCENSIA DIABETES CARE CONTOUR NEXT ONE Blood Glucose Monitoring System 11/17/2016
K162336 Ascensia Diabetes Care US Inc. Contour Next EZ Blood Glucose Monitoring System 01/12/2017
K160430 Ascensia Diabetes Care US Inc. Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System 06/24/2016
K023584 BAYER CORP. ASCENSIA DEX 2 DIABETES CARE SYSTEM 11/20/2002
K024234 BAYER CORP. ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL 01/23/2003
K012205 BAYER CORP. GLUCOMETER DEX TEST SENSOR 09/12/2001
K020210 BAYER GROUP DIAGNOSTICS GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED) 04/30/2002
K020208 BAYER GROUP DIAGNOSTICS GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) 04/29/2002
K060470 BAYER HEALTHCARE ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 04/12/2006
K062058 BAYER HEALTHCARE ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 09/11/2006
K122370 BAYER HEALTHCARE CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR 09/26/2013
K121087 BAYER HEALTHCARE CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM 06/28/2012
K150942 BAYER HEALTHCARE Contour Next USB Blood Glucose Monitoring System 11/25/2015
K091820 BAYER HEALTHCARE CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM 08/26/2009
K130265 BAYER HEALTHCARE LLC CONTOUR NEXT EZ BLOOD GLUCOSE METER 06/23/2014
K093930 BAYER HEALTHCARE LLC DIDGET WORLD REPORTS 03/12/2010
K062347 BAYER HEALTHCARE, LLC ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM 11/22/2006
K043158 BAYER HEALTHCARE, LLC ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM 12/22/2004
K043311 BAYER HEALTHCARE, LLC ASCENSIA ELITE DIABETES CARE SYSTEM 12/22/2004
K090628 BAYER HEALTHCARE, LLC DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 12/04/2009
K082486 BAYER HEALTHCARE, LLC GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE 10/08/2008
K023219 BECTON DICKINSON & CO. BECTON DICKINSON DIABETES SOFTWARE 12/06/2002
K022581 BECTON DICKINSON & CO. BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM 10/09/2002
K040603 BECTON DICKINSON & CO. PARADIGM LINK BLOOD GLUCOSE METER 05/19/2004
K090389 BESTGEN BIOTECH CORP. AP-1000 BLOOD GLUCOSE MONITORING SYSTEM 07/14/2009
K100437 BESTGEN BIOTECH CORP. AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION 01/12/2012
K103044 BESTGEN BIOTECH CORP. AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION 02/10/2012
K072274 BESTGEN BIOTECH CORP. MAJOR III BLOOD GLUCOSE MONITORING SYSTEM 02/29/2008
K122307 BIOCARE CORPORATION DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM 04/05/2013
K143387 Bionime Coporation GE333 Blood Glucose Monitoring System 06/03/2015
K141292 BIONIME COPORATION Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System 06/09/2015
K133522 BIONIME COPORATION RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM 04/17/2014
K120423 BIONIME CORPORATION BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 08/03/2012
K170143 Bionime Corporation GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, 07/06/2017
K161790 BIONIME CORPORATION iGlucose Blood Glucose Monitoring System 05/02/2017
K053635 BIONIME CORPORATION MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM 02/21/2006
K062567 BIONIME CORPORATION RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM 02/16/2007
K042678 BIONIME CORPORATION RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM 01/03/2005
K140210 BIONIME CORPORATION RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 08/22/2014
K110737 BIONIME CORPORATION RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 03/29/2012
K123008 BIONIME CORPORATION RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN 01/25/2013
K173638 Bionime Corporation Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus 08/17/2018
K173139 Bionime Corporation Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus 06/19/2018
K081451 BIONIME CORPORATION RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 09/18/2008
K081450 BIONIME CORPORATION RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 09/11/2008
K072054 BIONIME CORPORATION RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 02/28/2008
K092052 BIONIME CORPORATION RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 06/18/2010
K053312 BIOPTIK TECHNOLOGY, INC. EASYMATE BLOOD GLUCOSE MONITORING SYSTEM 03/01/2006
K133509 Biotest Medical Corp. EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO 02/21/2014
K100560 Biotest Medical Corp. EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 05/12/2010
K122525 Biotest Medical Corp. SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM 05/02/2013
K100701 Biotest Medical Corp. SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 04/08/2010
K093764 Biotest Medical Corp. SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM 03/02/2010
K123559 Biotest Medical Corp. SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM 06/28/2013
K091815 Biotest Medical Corp. SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 11/16/2009
K141351 Biotest Medical Corp. SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM 05/19/2015
K171822 Biotest Medical Corporation NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) 09/20/2017
K171785 Biotest Medical Corporation WowGoHealth Blood Glucose Monitoring System 09/15/2017
K120183 BROADMASTER BIOTECH CORPERATION ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM 05/11/2012
K130621 BROADMASTER BIOTECH CORPORATION BROADMASTER HEALTHCARE SYSTEM 07/30/2013
K032029 BT MEDICAL BTG SMARTEST GLUCOSE TEST SYSTEM 12/18/2003
K102383 CAMBRIDGE SENSORS LIMITED MICRODOT & MICRODOT XTRA 01/27/2012
K070524 CAMBRIDGE SENSORS LIMITED MICRODOT BLOOD GLUCOSE MONITORING SYSTEM 06/22/2007
K083273 CAMBRIDGE SENSORS LIMITED MICRODOT XTRA 11/19/2009
K082521 CARD GUARD SCIENTIFIC SURVIVAL, LTD. EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM 01/16/2009
K141829 CERAGEM MEDISYS INC. GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM 09/24/2014
K140141 CERAGEM MEDISYS INC. LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM 07/03/2014
K102751 CERAGEM MEDISYS INC. LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM 02/11/2013
K010039 CHRONIMED, INC. QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION 08/10/2001
K131363 CILAG GMBH INTERNATIONAL ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM 08/30/2013
K120708 CILAG GMBH INTERNATIONAL ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM 02/07/2013
K120866 DELBIO INCORPORATION DA01 BLOOD GLUCOSE MONITORING SYSTEM 12/11/2012
K132338 DELBIO INCORPORATION DA01 BLOOD GLUCOSE MONITORING SYSTEM 10/24/2013
K100806 DELBIO INCORPORATION DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM 09/16/2011
K113343 DELBIO INCORPORATION DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM 02/08/2012
K130244 DELBIO INCORPORATION DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM 08/23/2013
K103329 DELBIO INCORPORATION DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION 03/13/2012
K062538 DIACARE CORP. EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM 04/30/2007
K053593 DIAGNOSTIC DEVICES INC. PRODIGY 07/06/2006
K073118 DIAGNOSTIC DEVICES INC. PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM 03/05/2008
K060467 DIAGNOSTIC DEVICES, INC. PRODIGY BLOOD GLUCOSE TEST SYSTEM 07/13/2006
K052343 E-SAN LIMITED E-SAN BLUETOOTH CRADLE 12/07/2005
K061328 E-SAN LIMITED THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) 06/13/2006
K143169 ENTRA HEALTH SYSTEMS MyGlucoHealth Wireless System 01/08/2016
K081703 ENTRA HEALTH SYSTEMS, LTD. MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS 01/08/2009
K182057 EPS Bio Technology Corp. EasyMax BT Self-Monitoring Blood Glucose System 08/24/2018
K083099 EPS BIO TECHNOLOGY CORP. EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 01/16/2009
K102345 EPS BIO TECHNOLOGY CORP. EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 06/21/2011
K092894 EPS BIO TECHNOLOGY CORP. EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM 02/24/2010
K092887 EPS BIO TECHNOLOGY CORP. EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 10/21/2009
K091481 EPS BIO TECHNOLOGY CORP. EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM 08/18/2009
K081796 EPS BIO TECHNOLOGY CORP. EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM 01/23/2009
K101457 EPS BIO TECHNOLOGY CORP. EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 07/01/2010
K070053 EPS BIO TECHNOLOGY CORP. EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 12/03/2007
K133389 EPS BIO TECHNOLOGY CORP. EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM 04/15/2014
K133647 EPS BIO TECHNOLOGY CORP. EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM 02/27/2014
K091229 EPS BIO TECHNOLOGY CORP. GLUCOMANAGER DATA MANAGEMENT SOFTWARE 07/31/2009
K040678 EUMED BIOTECHNOLOGY CO., LTD. EUSURE BLOOD GLUCOSE MONITORING SYSTEM 07/14/2004
K070239 EXIR PHARMACEUTICAL CO. MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM 05/25/2007
K173505 ForaCare Inc. FORA GTel Blood Glucose Monitoring System 08/09/2018
K123090 GENERAL LIFE BIOTECHNOLOGY CO., LTD. GLB BENECHECK PREMIUM GLU MONITORING SYSTEM 11/22/2013
K123136 GENESIS HEALTH TECHNOLOGIES GENESIS HEALTH RECORD SYSTEM, (GHRS) 03/07/2013
K080853 GENEXEL-SEIN, INC. DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM 02/20/2009
K132272 GLOOKO, INC. GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION 10/17/2013
K130886 GLOOKO, INC. GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION 04/25/2013
K122142 GLOOKO, INC. GLOOKO LOGBOOK CHARTS 12/21/2012
K061234 GLUCOPLUS INC GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM 10/30/2006
K141862 H2 Inc. HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE 12/02/2014
K110074 HEALTH & LIFE CO., LTD. HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM 05/25/2012
K052469 HEALTHPIA AMERICA CORP. GLUCOPACK 06/05/2006
K072369 HMD BIOMEDICAL LLC EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM 03/21/2008
K131173 HMD BIOMEDICAL, INC. FIA Blood Glucose Monitoring System (G2) 09/18/2014
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K100322 TaiDoc Technology Corporation TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 06/28/2010
K151100 TAIDOC TECHNOLOGY CORPORATION U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System 09/29/2015
K090188 TaiDoc Technology Corporation U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 07/13/2009
K092902 TaiDoc Technology Corporation U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC 03/02/2010
K081957 TaiDoc Technology Corporation U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM 08/05/2008
K101509 TaiDoc Technology Corporation U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM 06/27/2011
K082618 TaiDoc Technology Corporation ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455 10/07/2008
K110571 TELCARE, INC. TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE 07/28/2011
K111456 TIANJIN EMPECS MEDICAL DEVICE CO., LTD. MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM 02/28/2012
K133260 TIANJIN EMPECS MEDICAL DEVICE CO., LTD. MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM 06/27/2014
K152534 TIANJIN EMPECS MEDICAL DEVICE CO., LTD. Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose M 03/21/2017
K162564 Tianjin Empecs Medical Device Co.,Ltd. Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 06/07/2017
K052208 Tianjin New Bay Bioresearch Co., Ltd. GLUCOSE PILOT 12/09/2005
K143548 Trividia Health, Inc. TRUE METRIX GO Self Monitoring Blood Glucose System 04/01/2016
K072854 TYSON BIORESEARCH, INC. DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM 06/30/2008
K062829 TYSON BIORESEARCH, INC. DIACHEX BLOOD GLUCOSE MONITORING SYSTEM 10/10/2006
K073492 TYSON BIORESEARCH, INC. DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM 04/08/2008
K090629 TYSON BIORESEARCH, INC. EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS 06/04/2009
K072441 TYSON BIORESEARCH, INC. EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM 03/25/2008
K052818 TYSON BIORESEARCH, INC. EZ SMART-168 GLUCOSE MONITORING SYSTEM 06/16/2006
K170079 TYSON BIORESEARCH, INC. Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System 10/06/2017
K123087 TYSON BIORESEARCH, INC. TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM 06/18/2013
K101543 TYSON BIORESEARCH, INC. TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 08/30/2011
K081726 TYSON BIORESEARCH, INC. TYSONBIO LINK HEALTH MANAGEMENT SYSTEM 08/26/2008
K112916 TYSON BIORESEARCH, INC. TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM 08/21/2012
K051651 U. S. DIAGNOSTICS, INC. G4, MODEL IGM-0004 04/14/2006
K113135 UNISTRIP TECHNOLOGIES, LLC UNISTRIP 1 11/06/2013
K110435 US DIAGNOSTICS, INC. EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM 09/21/2011
K082201 US DIAGNOSTICS, INC. G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A 02/20/2009
K043340 VIP DIAGNOSTICS LLC EZ SMART 06/02/2005
K040848 VIP INTERNATIONAL WHOLESALERS, CORP. EZ SMART 08/11/2004
K091765 VISGENEER, INC. EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM 01/19/2010
K122181 VISGENEER, INC. EBCHEK BLOOD GLUCOSE MONITORING SYSTEM 08/15/2013
K062555 VISGENEER, INC. EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G 12/27/2006
K160179 VIVACHEK LABORATORIES, INC. VivaChek Ino Blood Glucose Monitoring System 04/21/2017


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