FDA 510(k) Application Details - K124056

Device Classification Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers   More FDA Info for this Device
510(K) Number	K124056
Device Name	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Applicant	NANOEN TEK, INC. 1 JACK'S HILL RD. SUITE 1 (A&B) OXFORD, CT 06478 US Other 510(k) Applications for this Company
Contact	JUDITH E LOEBEL 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	12/31/2012
Decision Date	05/29/2013
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