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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 61 of 61 Results
ProductCode: NBW Decision Date From: 01/01/2012 Decision Date To: 12/31/2012
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glooko logbook charts GLOOKO, INC. K122142 12/21/2012
nova one blood glucose monitor NOVA BIOMEDICAL CORPORATION K122435 12/20/2012
on call vivid blood glucose monitoring system ACON LABORATORIES, INC. K123010 12/14/2012
da01 blood glucose monitoring system DELBIO INCORPORATION K120866 12/11/2012
omnipod insulin managment system INSULET CORPORATION K122953 12/07/2012
blood glucose monitoring system ANDON MEDICAL CO., LTD K120813 12/07/2012
genstrip test strip model 100-201 SHASTA TECHNOLOGIES, LLC K103542 11/30/2012
acon on call vivid pal blood glucose monitoring system ACON LABORATORIES, INC. K122110 11/21/2012
accu-chek inform ii blood glucose monitoring system Roche Diagnostics K121679 10/11/2012
genesis health technologies blood glucose monitoring system TaiDoc Technology Corporation K121224 09/19/2012
test, blood glucose system HMD BIOMEDICAL, INC. K120064 09/05/2012
auto-chek blood glucose monitoring system, meter, test strip. auto-check control solution i-SENS, Inc. K121654 09/05/2012
clever choice SIMPLE DIAGNOSTICS, INC. K120921 08/21/2012
tysonbio md100 blood glucse monitoring ,tysonbio md100 pro blood glucise monitoring system TYSON BIORESEARCH, INC. K112916 08/21/2012
connected care clinical application WATERMARK MEDICAL INC K120320 08/14/2012
bioland g-423 glood glucose monitoring system TaiDoc Technology Corporation K113077 08/03/2012
bionime rightest blood glucose monitoring system, model gm650 BIONIME CORPORATION K120423 08/03/2012
gl goodlife series blood glucose monitoring sysmtem HMD BIOMEDICAL, INC. K113307 07/27/2012
contour next blood glucose meter BAYER HEALTHCARE LLC K121190 07/26/2012
connected care mobile application WATERMARK MEDICAL K120325 07/18/2012
accu-check combo system Roche Diagnostics K111353 07/17/2012
vignet telehealth manager VIGNET INC. K113446 07/16/2012
healthpro blood glucose monitoring system INFOPIA CO., LTD K113192 07/13/2012
caresens n voice blood glucose monitoring system i-SENS, Inc. K121133 07/10/2012
autosure voice 3 plus blood glucose monitoring system APEX BIO TECHNOLOGY CORP K120649 07/06/2012
constant care lilah home health monitoring system CONSTANT CARE, LLC K120941 07/03/2012
contour next usb blood glucose monitoring system BAYER HEALTHCARE K121087 06/28/2012
caresens n mini blood glucose monitoring system, mini blood glucose meter, blood glucose test strip, control solution i-SENS, Inc. K120759 06/05/2012
hl 568 self monitoring blood glucose system, hl 568ba self-moniroting blood glucose system HEALTH & LIFE CO., LTD. K110074 05/25/2012
td-4268 blood glucose monitoring system td-4268 multi blood glucose monitoring system TaiDoc Technology Corporation K120042 05/22/2012
easymax mu self monitoring blood glucose system, easymax mu pro self monitoring blood glucose system EPS BIO TECHNOLOGY CORP. K121207 05/18/2012
advocate redi-code+bmb-ea001s blood glucose monitoring system BROADMASTER BIOTECH CORPERATION K120183 05/11/2012
element blood glucose monitoring system INFOPIA CO., LTD K113670 05/08/2012
caresens n pop blood glucose monitoring system caresens n pop blood glucose meter caresens n blood glucose test strip ca i-SENS, Inc. K120351 05/03/2012
ap-3000 blood glucose monitoring system, major glucose control solution BESTGEN BIOTECH CORP. K103230 04/24/2012
on call chosen lancing device ACON LABORATORIES, INC. K113332 04/18/2012
u-right td-4280 blood glucose monitoring system TaiDoc Technology Corporation K113768 04/12/2012
on call vivid blood glucose monitoring systems ACON LABORATORIES, INC. K112653 04/09/2012
meg-2b blood glucose monitoring system, pro blood glucose monitoring system, blood glucose test strips, glucose control APEX BIOTECHNOLOGY CORP. K120448 04/06/2012
freestyle insulinx blood glucose monitoring system ABBOTT DIABETES CARE INC. K120568 03/29/2012
rightest blood glucose monitoring system gm700 BIONIME CORPORATION K110737 03/29/2012
contour link blood glucose meter, contour blood glucose test strips, contour control solution (high, normal, low) BAYER HEALTHCARE, LLC K110587 03/28/2012
contour next link wireless blood glucose meter BAYER HEALTHCARE K110894 03/28/2012
gal-1e blood glucose monitoring system gal-1e blood glucose test strips gal-1e multi blood glucose monitoring system gal APEX BIOTECHNOLOGY CORP. K113547 03/28/2012
em50 self monitoring blood glucose system EPS BIO TECHNOLOGY CORP. K113243 03/28/2012
ap-2000, ap-2010, and ap-2020 blood glucose monitoring system BESTGEN BIOTECH CORP. K103116 03/13/2012
diatrue plus blood glucose monitoring system; diatrue plus blood glucose test strip; diatrue glucose control solution DELBIO INCORPORATION K103329 03/13/2012
nova max one blood glucose monitor, nova max one blood glucose test strips NOVA BIOMEDICAL CORPORATION K112638 03/09/2012
contour (r) next blood glucose monitoring system BAYER HEALTHCARE K111268 03/06/2012
medisign blood glucose monitoring system TIANJIN EMPECS MEDICAL DEVICE CO., LTD. K111456 02/28/2012
bionime diabetes management system vi.0 BIONIME CORPORATION K113007 02/27/2012
freestyle insulinx blood glucose monitoring systems ABBOTT LABORATORIES K111874 02/16/2012
ap-1010 and ap-1020 blood glucose monitoring system, major glucose control solution BESTGEN BIOTECH CORP. K103044 02/10/2012
diacheck smart/superior blood glucose monitoring system DELBIO INCORPORATION K113343 02/08/2012
fora diamond prima blood glucose monitoring system, fora diamond mini blood glucose monitoring system TaiDoc Technology Corporation K111890 02/06/2012
microdot & microdot xtra CAMBRIDGE SENSORS LIMITED K102383 01/27/2012
gal-1a blood glucose monitoring system APEX BIOTECHNOLOGY CORP. K113208 01/26/2012
ag-608n blood glucose monitoring system ANDON MEDICAL CO., LTD. K110017 01/18/2012
autosure voice ii plus, autosure plus blood glucose test strips,contrex plus iii APEX BIOTECHNOLOGY CORP. K113098 01/17/2012
ap-1000 blood glucose monitoring system, model ap-1000, major glucose control solution BESTGEN BIOTECH CORP. K100437 01/12/2012
glucose test system Roche Diagnostics K113137 01/06/2012
 
 
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