FDA 510(k) Application Details - K163713

Device Classification Name	Reagent, Borrelia Serological Reagent   More FDA Info for this Device
510(K) Number	K163713
Device Name	Reagent, Borrelia Serological Reagent
Applicant	Quidel Corporation 12544 High Bluff Drive, Suite 200 San Diego, CA 92130 US Other 510(k) Applications for this Company
Contact	Jennifer S Rial 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	12/30/2016
Decision Date	10/20/2017
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