FDA 510(k) Application Details - K964595

Device Classification Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers   More FDA Info for this Device
510(K) Number	K964595
Device Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Applicant	BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. WESTWOOD, MA 02090 US Other 510(k) Applications for this Company
Contact	KATHLEEN DRAY-LYONS Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	LTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/1996
Decision Date	06/24/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review