FDA 510(k) Application Details - K141827

Device Classification Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K141827
Device Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	EUROIMMUN U.S., Inc. 1100 THE AMERICAN ROAD MORRIS PLAINS, NJ 07950 US Other 510(k) Applications for this Company
Contact	MICHAEL A LOCKE Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	DHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2014
Decision Date	04/17/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review