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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 K992492
Device Name PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
Applicant
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Applicant Contact LUANN OCHS
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Correspondent Contact LUANN OCHS
Regulation Number864.7750
Classification Product Code
GJS  
Date Received07/26/1999
Decision Date 11/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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