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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
510(k) Number K000492
Device Name MDA D-DIMER
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
DAP  
Date Received02/15/2000
Decision Date 06/07/2000
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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