FDA 510(k) Application Details - K233688

Device Classification Name	More FDA Info for this Device
510(K) Number	K233688
Device Name	Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
Applicant	Quidel Corporation 10165 McKellar Court San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Xiaoxi Wang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2023
Decision Date	12/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review