FDA 510(k) Application Details - K162438

Device Classification Name	More FDA Info for this Device
510(K) Number	K162438
Device Name	Sofia Influenza A+B FIA on Sofia 2
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	More FDA Info for this Regulation Number
Classification Product Code	PSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2016
Decision Date	04/14/2017
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