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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 Split Products, Peroxidase, Antigen, Antiserum, Control
510(k) Number K924892
Device Name FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM
Applicant
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Applicant Contact RON SANLYAL
Correspondent
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Correspondent Contact RON SANLYAL
Regulation Number864.7340
Classification Product Code
DAT  
Date Received09/29/1992
Decision Date 04/21/1994
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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