FDA 510(k) Application Details - K062028

Device Classification Name	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection   More FDA Info for this Device
510(K) Number	K062028
Device Name	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Applicant	CELERA DIAGNOSTICS 1401 HARBOR BAY PKWY. ALAMEDA, CA 94502 US Other 510(k) Applications for this Company
Contact	VICTORIA MACKINNON 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	07/18/2006
Decision Date	09/07/2007
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