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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prothrombin, Antigen, Antiserum, Control
510(k) Number K910617
Device Name NATIVE PROTHROMBIN ANTIGEN EIA
Applicant
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Applicant Contact ANN M QUINN
Correspondent
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Correspondent Contact ANN M QUINN
Regulation Number866.5735
Classification Product Code
DDF  
Date Received02/12/1991
Decision Date 05/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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