FDA 510(k) Application Details - K153012

Device Classification Name	More FDA Info for this Device
510(K) Number	K153012
Device Name	Sofia Influenza A+B FIA
Applicant	QUIDEL CORPORATION 12544 HIGH BLUFF DRIVE, SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	EDWARD C. BREHM 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	10/14/2015
Decision Date	01/12/2016
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