FDA 510(k) Application Details - K161513

Device Classification Name	Reagent, Borrelia Serological Reagent   More FDA Info for this Device
510(K) Number	K161513
Device Name	Reagent, Borrelia Serological Reagent
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	866.3830   More FDA Info for this Regulation Number
Classification Product Code	LSR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2016
Decision Date	08/25/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review