FDA 510(k) Application Details - DEN080007

Device Classification Name	Cardiac Allograft Gene Expression Profiling Test System   More FDA Info for this Device
510(K) Number	DEN080007
Device Name	Cardiac Allograft Gene Expression Profiling Test System
Applicant	XDX 3260 BAYSHORE BOULEVARD BRISBANE, CA 94005 US Other 510(k) Applications for this Company
Contact	ROSE ROMEO Other 510(k) Applications for this Contact
Regulation Number	862.1163   More FDA Info for this Regulation Number
Classification Product Code	OJQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2008
Decision Date	08/26/2008
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review