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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 27 Results
ProductCode: NBW Applicant: ROCHE DIAGNOSTICS Decision Date To: 03/04/2015
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accu-chek performa blood glucose monitor roche diagnostics K133741 08/29/2014
accu-chek aviva plus system roche diagnostics corporation K133862 04/29/2014
accu-chek aviva plus test strip roche diagnostics operations inc K131029 08/09/2013
super sani-cloth/ accu-chek inform ii sy roche diagnostics corp. K130138 03/15/2013
accu-check compact plus blood glucose mo roche diagnostics K113614 02/12/2013
accu-chek inform ii blood glucose monito roche diagnostics K121679 10/11/2012
accu-check combo system roche diagnostics K111353 07/17/2012
glucose test system roche diagnostics K113137 01/06/2012
accu-chek aviva plus blood glucose monit roche diagnostics K101299 09/21/2011
accu-chek compact plus blood glucose mon roche diagnostics K081389 07/15/2008