FDA 510(k) Application Details - K963902

Device Classification Name	Test, Fibrinogen   More FDA Info for this Device
510(K) Number	K963902
Device Name	Test, Fibrinogen
Applicant	ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 RARITAN, NJ 08869-0606 US Other 510(k) Applications for this Company
Contact	BLANCHE CHIEN Other 510(k) Applications for this Contact
Regulation Number	864.7340   More FDA Info for this Regulation Number
Classification Product Code	GIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/1996
Decision Date	11/29/1996
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