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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 K911434
Device Name THROMBONOSTIKA F1.2
Applicant
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Applicant Contact THOMAS S CLEMENT
Correspondent
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Correspondent Contact THOMAS S CLEMENT
Regulation Number864.7320
Classification Product Code
MIF  
Date Received04/02/1991
Decision Date 10/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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