FDA 510(k) Application Details - K994221

Device Classification Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers   More FDA Info for this Device
510(K) Number	K994221
Device Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Applicant	BAYER CORP. 63 NORTH ST. MEDFIELD, MA 02052-1688 US Other 510(k) Applications for this Company
Contact	William J Pignato 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	12/15/1999
Decision Date	04/13/2000
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