FDA 510(k) Application Details - K200023

Device Classification Name	Reagent, Borrelia Serological Reagent   More FDA Info for this Device
510(K) Number	K200023
Device Name	Reagent, Borrelia Serological Reagent
Applicant	Gold Standard Diagnostics 2851 Spafford St. Davis, CA 95618 US Other 510(k) Applications for this Company
Contact	Napoleon Monce Other 510(k) Applications for this Contact
Regulation Number	866.3830   More FDA Info for this Regulation Number
Classification Product Code	LSR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/2020
Decision Date	04/06/2020
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