FDA 510(k) Application Details - K131330

Device Classification Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls   More FDA Info for this Device
510(K) Number	K131330
Device Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant	GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD Davis, CA 95618 US Other 510(k) Applications for this Company
Contact	NAPOLEON MONCE Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2013
Decision Date	01/28/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review