FDA 510(k) Application Details - K954997

Device Classification Name	System, Automated Platelet Aggregation   More FDA Info for this Device
510(K) Number	K954997
Device Name	System, Automated Platelet Aggregation
Applicant	CENTOCOR, INC. 200 GREAT VALLEY PKWY. MALVERN, PA 19355-1307 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER ZALESKY Other 510(k) Applications for this Contact
Regulation Number	864.5700   More FDA Info for this Regulation Number
Classification Product Code	JOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/1995
Decision Date	01/24/1996
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