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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 K060978
Device Name COAGUCHEK XS SYSTEM
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianpolis,  IN  46256
Applicant Contact JENNIFER TRIBBETT
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianpolis,  IN  46256
Correspondent Contact JENNIFER TRIBBETT
Regulation Number864.7750
Classification Product Code
GJS  
Date Received04/10/2006
Decision Date 08/11/2006
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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