FDA 510(k) Application Details - K964351

Device Classification Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers   More FDA Info for this Device
510(K) Number	K964351
Device Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Applicant	BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 CONCORD, CA 94524-4117 US Other 510(k) Applications for this Company
Contact	MARY KONING 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	11/01/1996
Decision Date	07/25/1997
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