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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 28 Results
ProductCode: NBW Applicant: ROCHE DIAGNOSTICS Decision Date To: 02/22/2017
 
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super sani-cloth/ accu-chek inform ii system ROCHE DIAGNOSTICS CORP. K130138 03/15/2013
modification to accu-chek inform meter ROCHE DIAGNOSTICS CORP. K012210 08/09/2001
modification to accu-chek go system ROCHE DIAGNOSTICS CORP. K051592 09/02/2005
modification to accu-chek active system ROCHE DIAGNOSTICS CORP. K021448 06/03/2002
modification to accu-chek active system ROCHE DIAGNOSTICS CORP. K021827 07/03/2002
glucose test system Roche Diagnostics K113137 01/06/2012
accuchek instant plus dual testing system, accuchek instant plus cholesterol, accuchek instant plus glucocose Roche Diagnostics K051376 08/23/2005
accu-chek smart pix ROCHE DIAGNOSTICS CORP. K062395 05/09/2007
accu-chek performa system ROCHE DIAGNOSTICS CORP. K070585 05/25/2007
accu-chek performa blood glucose monitoring system Roche Diagnostics K133741 08/29/2014
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