FDA 510(k) Application Details - DEN140010

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140010
Device Name	PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
Applicant	WALLAC OY 940 WINTER STREET WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	KAY A TAYLOR Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2014
Decision Date	12/15/2014
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review