FDA 510(k) Application Details - DEN050004

Device Classification Name	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection   More FDA Info for this Device
510(K) Number	DEN050004
Device Name	System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Applicant	TM BIOSCIENCE CORPORATION 439 UNIVERSITY AVE., SUITE 900 TORONTO, ONTARIO M5G 1Y8 CA Other 510(k) Applications for this Company
Contact	NANCY KRUNIC 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	04/05/2005
Decision Date	05/09/2005
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review