FDA 510(k) Application Details - K153117

Device Classification Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K153117
Device Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	AESKU. SYSTEMS GMBH & CO. KG MIKROFORUM RING 3 WENDELSHEIM 55234 DE Other 510(k) Applications for this Company
Contact	TOM STECKLUM 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	10/28/2015
Decision Date	07/28/2016
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