FDA 510(k) Application Details - K180202

Device Classification Name	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K180202
Device Name	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Applicant	Immuno Concepts, NA, Ltd. 9825 Goethe Rd., 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	866.5660   More FDA Info for this Regulation Number
Classification Product Code	DBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2018
Decision Date	10/19/2018
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