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U.S. Department of Health and Human Services

510(k) Premarket Notification

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21 to 28 of 28 Results
ProductCode: NBW Applicant: ROCHE DIAGNOSTICS Decision Date To: 10/26/2016
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accu-chek smart pix ROCHE DIAGNOSTICS CORP. K062395 05/09/2007
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
modification to accu-chek go system ROCHE DIAGNOSTICS CORP. K051592 09/02/2005
modification to accu-chek inform meter ROCHE DIAGNOSTICS CORP. K012210 08/09/2001
super sani-cloth/ accu-chek inform ii system ROCHE DIAGNOSTICS CORP. K130138 03/15/2013
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
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