FDA 510(k) Application Details - K994419

Device Classification Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers   More FDA Info for this Device
510(K) Number	K994419
Device Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Applicant	QUALISYS DIAGNOSTICS, INC. 2042 CORTE DEL NOGAL CARLSBAD, CA 92009 US Other 510(k) Applications for this Company
Contact	VIJAY K MAHANT 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	12/29/1999
Decision Date	06/28/2000
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