FDA 510(k) Application Details - DEN140002

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140002
Device Name	EUROIMMUN ANTI-PLA2R IFA
Applicant	EUROIMMUN US 1100 THE AMERICAN ROAD MORRIS PLAINS, NJ 07950 US Other 510(k) Applications for this Company
Contact	MICHAEL LOCKE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2014
Decision Date	05/29/2014
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review