FDA 510(k) Application Details - K160265

Device Classification Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K160265
Device Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	Immuno Concepts, NA, Ltd. 9825 Goethe Road; Suite 350 Sacramento, CA 95827 US Other 510(k) Applications for this Company
Contact	Eric S. Hoy 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	02/02/2016
Decision Date	06/17/2016
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