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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 K062925
Device Name COAGUCHEK XS SYSTEM
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46256
Applicant Contact THERESA BUSH
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46256
Correspondent Contact THERESA BUSH
Regulation Number864.7750
Classification Product Code
GJS  
Date Received09/28/2006
Decision Date 01/29/2007
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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