FDA 510(k) Application Details - K002313

Device Classification Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers   More FDA Info for this Device
510(K) Number	K002313
Device Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Applicant	ONCOGENE SCIENCE, INC. 80 ROGERS ST. CAMBRIDGE, MA 02142 US Other 510(k) Applications for this Company
Contact	SHERYL BROWN-SHIMER 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	07/31/2000
Decision Date	08/30/2000
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