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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 35 of 35 Results
ProductCode: NBW Decision Date From: 01/01/2015 Decision Date To: 12/31/2015
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dario blood glucose monitoring system LabStyle Innovations Ltd. K150817 12/21/2015
freestyle freedom blood glucose monitoring sytem ABBOTT LABORATORIES K152442 12/17/2015
prodigy iconnect blood glucose monitoring system OK BIOTECH CO., LTD. K142785 12/17/2015
onetouch ultra plus flex blood glucose monitoring system LIFESCAN EUROPE K151611 12/14/2015
ihealth align gluco-monitoring system, ihealth bg5 wireless smart gluco-monitoring system, ihealth bg5l wireless smart gluco-monitoring system ANDON HEALTH CO.,LTD K150833 12/04/2015
gmate origin blood glucose monitoring system Philosys Inc. K151658 12/01/2015
contour next usb blood glucose monitoring system BAYER HEALTHCARE K150942 11/25/2015
sd gluconfc blood glucose monitoring system, sd gluconfc multi blood glucose monitoring system SD BIOSENSOR K151265 11/24/2015
gmate smart blood glucose monitoring system Philosys Inc. K150299 11/19/2015
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 APEX BIOTECHNOLOGY CORP. K150396 10/14/2015
joinsoon eon l glucose monitoring system and joinsoon eon ls glucose monitoring system JOINSOON MEDICAL TECHNOLOGY CO, LTD. K140325 10/13/2015
gmate mini blood glucose monitoring system, gmate step blood glucose monitoring system Philosys Inc. K141656 10/02/2015
freestyle precision neo blood glucose monitoring system ABBOTT DIABETES CARE INC K142928 09/30/2015
u-right td-4116 blood glucose monitoring system, u-right td-4116 pro blood glucose monitoring system TAIDOC TECHNOLOGY CORPORATION K151100 09/29/2015
freestyle insulinx blood glucose monotioring system ABOTT LABORATORIES K152328 09/17/2015
on call express pro blood glucose monitoring system ACON Laboratories, Inc. K151595 09/05/2015
gdh professional blood glucose monitoring system and gdh professional led blood glucose monitoring system Infopia Co., Ltd. K150274 08/26/2015
assure prism multi blood glucose monitoring system i-Sens, Inc. K151164 08/07/2015
gal-1f blood glucose monitoring system, gal-1f pro blood glucose monitoring system Apex BioTechnology Corp. K142689 08/06/2015
sd gluconavii mentor nfc multi blood glucose monitoring system, and sd gluconavii mentor nfc blood glucose monitoring system SD BIOSENSOR, INC. K132929 08/05/2015
onetouch verio flex blood glucose monitoring system LIFESCAN EUROPE K150214 07/31/2015
rightest blood glucose monitoring system gm700, rightest blood glucose monitoring system gm650, ge200 blood glucose monitoring system, and ge300 talking blood glucose monitoring system BIONIME COPORATION K141292 06/09/2015
freestyle lite blood glucose monitoring system ABBOTT LABORATORIES K150332 06/05/2015
freestyle freedom lite blood glucose monitoring system Abbott Laboratories K150531 06/05/2015
ge333 blood glucose monitoring system Bionime Coporation K143387 06/03/2015
cardiochek plus test system, cardiochek home test system POLYMER TECHNOLOGY SYSTEMS, INC. K140068 05/22/2015
supercheck plus blood glucose monitoring system, super check plus multi blood glucose monitoring system Biotest Medical Corp. K141351 05/19/2015
goodlife ac-300 blood glucose monitoring system, goodlife ac-301 blood glucose monitoring system, goodlife ac-302 blood glucose monitoring system, goodlife ac 303 blood glucose monitoring system, goodlife ac-304 blood glucose monitoring system goodlife ac-305 blood glucos HMD BIOMEDICAL, INC. K140150 05/14/2015
meg-2b blood glucose monitoring system, meg-2b pro blood glucose monitoring system APEX BIO TECHNOLOGY CORP K143750 05/07/2015
fora gd43 blood glucose monitoring system TaiDoc Technology Corporation K143467 05/07/2015
bgm009 blood glucose monitoring system APEX BIOTECHNOLOGY CORP. K141036 05/01/2015
i-qare ds-w blood glucose monitoring system ALLIANCE INTERNATIONAL CO., LTD. K132663 04/20/2015
prodigy autocode eject blood glucose monitoring system OK BIOTECH CO., LTD. K141914 04/15/2015
true metrix air self-monitoring blood glucose system, true metrix air pro professional blood gulcose monitoring system Nipro Diagnostics, Inc K150052 03/26/2015
accu-chek aviva connect blood glucose monitoring system Roche Diagnostics K141867 03/03/2015
 
 
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