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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K093460
Device Name COAGUCHEK XS PRO SYSTEM
Applicant
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Applicant Contact JENNIFER TRIBBETT
Correspondent
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Correspondent Contact JENNIFER TRIBBETT
Regulation Number864.7750
Classification Product Code
GJS  
Date Received11/06/2009
Decision Date 03/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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