FDA 510(k) Application Details - K163347

Device Classification Name	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection   More FDA Info for this Device
510(K) Number	K163347
Device Name	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Applicant	Luminex Molecular Diagnostics, Inc. 439 University Ave Toronto M5g1y8 CA Other 510(k) Applications for this Company
Contact	Tina Ip 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	11/28/2016
Decision Date	12/15/2016
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MG -
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review