FDA 510(k) Application Details - K083294

Device Classification Name	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection   More FDA Info for this Device
510(K) Number	K083294
Device Name	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Applicant	NANOSPHERE, INC 4088 COMMERCIAL AVENUE NORTHBROOK, IL 60062 US Other 510(k) Applications for this Company
Contact	GREGORT W SHIPP Other 510(k) Applications for this Contact
Regulation Number	866.5900   More FDA Info for this Regulation Number
Classification Product Code	NUA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2008
Decision Date	07/24/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review