FDA 510(k) Application Details - K101185

Device Classification Name	More FDA Info for this Device
510(K) Number	K101185
Device Name	NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
Applicant	IRIS MOLECULAR DIAGNOSTICS 2075 CORTE DEL NOGAL SUITE J CARLSBAD, CA 92011 US Other 510(k) Applications for this Company
Contact	ROBERT KLEM Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2010
Decision Date	09/20/2011
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