FDA 510(k) Application Details - K964718

Device Classification Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K964718
Device Name	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant	AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	ANDREW LOC B. LE Other 510(k) Applications for this Contact
Regulation Number	864.7320   More FDA Info for this Regulation Number
Classification Product Code	DAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/1996
Decision Date	05/23/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review