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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 13 Results
ProductCode: GJS Applicant: Roche Diagnostics Decision Date To: 04/25/2024
 
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coaguchek xs plus system Roche Diagnostics K180684 04/19/2018
coaguchek xs pro system Roche Diagnostics K180693 04/19/2018
coaguchek vantus system Roche Diagnostics K170960 12/25/2017
coaguchek xs pro system Roche Diagnostics K093460 03/18/2010
coaguchek xs plus pst system ROCHE DIAGNOSTICS CORP. K092940 03/05/2010
handheld base unit ROCHE DIAGNOSTICS CORP. K072920 01/31/2008
coaguchek xs plus system Roche Diagnostics K071041 05/11/2007
coaguchek xs system ROCHE DIAGNOSTICS CORP. K062925 01/29/2007
coaguchek xs system Roche Diagnostics K060978 08/11/2006
coaguchek pt.s test for prothrombin time self-testing ROCHE DIAGNOSTICS CORP. K030845 05/22/2003
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