FDA 510(k) Application Details - K083845

Device Classification Name	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection   More FDA Info for this Device
510(K) Number	K083845
Device Name	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Applicant	LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. TORONTO, ONTARIO M5G 1Y8 CA Other 510(k) Applications for this Company
Contact	GLORIA LEE 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	12/24/2008
Decision Date	12/11/2009
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