FDA 510(k) Application Details - K130794

Device Classification Name	System, Immunomagnetic, Circulating Cancer Cell, Enumeration   More FDA Info for this Device
510(K) Number	K130794
Device Name	System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Applicant	VERIDEX, LLC 1001 US HIGHWAY 202 NORTH RARITAN, NJ 08869-0606 US Other 510(k) Applications for this Company
Contact	KIMBERLY PRESCOTT Other 510(k) Applications for this Contact
Regulation Number	866.6020   More FDA Info for this Regulation Number
Classification Product Code	NQI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2013
Decision Date	06/20/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review