FDA 510(k) Application Details - K955638

Device Classification Name	Activated Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K955638
Device Name	Activated Partial Thromboplastin
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	864.7925   More FDA Info for this Regulation Number
Classification Product Code	GFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/1995
Decision Date	04/23/1996
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