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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 7 of 7 Results
ProductCode: GJS Applicant: ROCHE DIAGNOSTICS CORP. Decision Date To: 01/19/2022
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coaguchek xs plus pst system ROCHE DIAGNOSTICS CORP. K092940 03/05/2010
handheld base unit ROCHE DIAGNOSTICS CORP. K072920 01/31/2008
coaguchek xs system ROCHE DIAGNOSTICS CORP. K062925 01/29/2007
coaguchek pt.s test for prothrombin time self-testing ROCHE DIAGNOSTICS CORP. K030845 05/22/2003
pt-s test strips for the coaguchek system, model# 2032422 ROCHE DIAGNOSTICS CORP. K021190 10/25/2002
pt s test strips and controls for the coaguchek s system, models 2032422 and 3271404 ROCHE DIAGNOSTICS CORP. K020831 10/24/2002
ptn test cartridges for coaguchek pro system, ptn controls for coaguchek pro system ROCHE DIAGNOSTICS CORP. K992492 11/02/1999