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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prothrombin Fragment 1.2
510(k) Number K964934
Device Name THROMBONOSTIKA F1.2
Applicant
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Applicant Contact RON SANYAL
Correspondent
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Correspondent Contact RON SANYAL
Regulation Number864.7320
Classification Product Code
MIF  
Date Received12/09/1996
Decision Date 03/18/1997
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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