FDA 510(k) Application Details - K150358

Device Classification Name	Antigens, Nontreponemal, All   More FDA Info for this Device
510(K) Number	K150358
Device Name	Antigens, Nontreponemal, All
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	866.3820   More FDA Info for this Regulation Number
Classification Product Code	GMQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2015
Decision Date	11/12/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review