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U.S. Department of Health and Human Services

510(k) Premarket Notification
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11 to 20 of 28 Results
ProductCode: NBW Applicant: ROCHE DIAGNOSTICS Decision Date To: 04/25/2015
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accu-chek compact plus blood glucose monitoring system Roche Diagnostics K081389 07/15/2008
accu-chek performa system ROCHE DIAGNOSTICS CORP. K070585 05/25/2007
accu-chek smart pix ROCHE DIAGNOSTICS CORP. K062395 05/09/2007
accu-chek aviva test strips ROCHE DIAGNOSTICS CORP. K060620 08/11/2006
modification to accu-chek go system ROCHE DIAGNOSTICS CORP. K051592 09/02/2005
accuchek instant plus dual testing system, accuchek instant plus cholesterol, accuchek instant plus glucocose Roche Diagnostics K051376 08/23/2005
accu-chek integra system ROCHE DIAGNOSTICS CORP. K050872 05/02/2005
accu-chek aviva system ROCHE DIAGNOSTICS CORP. K043474 04/27/2005
accu-chek go system ROCHE DIAGNOSTICS CORP. K040796 04/22/2004
accu-chek advantage system ROCHE DIAGNOSTICS CORP. K032552 09/12/2003
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