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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 23 of 23 Results
ProductCode: NBW Decision Date From: 01/01/2016 Decision Date To: 12/31/2016
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bgm014 blood glucose monitoring system, bgm014 pro blood glucose monitoring system APEX BIOTECHNOLOGY CORP. K161299 12/23/2016
cardiochek plus test system, cardiochek home test system Polymer Technology Systems, Inc. d/b/a PTS Diagnostics K162282 12/22/2016
nocoding1 plus blood glucose monitoring system i-SENS, INC. K160742 12/16/2016
one drop blood glucose monitoring system AgaMatrix, Inc. K161834 11/30/2016
contour next one blood glucose monitoring system ASCENSIA DIABETES CARE K160682 11/17/2016
fora advanced gd40 and fora advanced gd40 pro blood glucose and ß-ketone monitoring systems TAIDOC TECHNOLOGY CORPORATION K161738 11/10/2016
ble smart blood glucose monitoring system, ble smart professional blood glucose monitoring system Infopia Co., Ltd. K160365 09/28/2016
accu-chek guide blood glucose monitoring system Roche Diabetes Care, Inc. K160944 08/31/2016
ihealth align gluco-monitoring system Andon health Co., Ltd K153286 08/19/2016
wireless smart gluco-monitoring system Andon Health Co., Ltd K153278 08/19/2016
on call pro blood glucose monitoring system ACON LABORATORIES K161867 08/05/2016
unistrip1 generic blood glucose test strips OK BIOTECH CO., LTD. K160038 07/29/2016
prodigy astro blood glucose monitoring system, prodigy astro pro blood glucose monitoring system OK BIOTECH CO., LTD. K152599 07/20/2016
contour next link wireless blood glucose monitoring system, contour next blood glucose monitoring system Ascensia Diabetes Care US Inc. K160430 06/24/2016
sd gluconavii mentor bt blood glucose monitoring system, sd gluconavii mentor bt multi blood glucose monitoring system SD BIOSENSOR K153201 06/24/2016
statstrip xpress blood glucose monitoring system NOVA BIOMEDICAL CORPORATION K160156 06/23/2016
lifestream management system, lifestream management suite, lifestream patient manager, lifestream manager, lifestream web manager, lifestream HONEYWELL HOMMED, LLC K153719 06/03/2016
omnipod insulin management system INSULET CORPORATION K160252 04/27/2016
pogo automatic blood glucose monitoring system INTUITY MEDICAL, INC K152493 04/25/2016
agamatrix jazz wireless 2 blood glucose monitoring system AgaMatrix, Inc. K152365 04/21/2016
true metrix go self monitoring blood glucose system Trividia Health, Inc. K143548 04/01/2016
freestyle precision neo h blood glucose monitoring system Abbott Diabetes Care Inc. K153330 02/19/2016
myglucohealth wireless system ENTRA HEALTH SYSTEMS K143169 01/08/2016