FDA 510(k) Application Details - K231795

Device Classification Name	More FDA Info for this Device
510(K) Number	K231795
Device Name	QuickVue COVID-19 Test
Applicant	Quidel Corporation 10165 McKellar Court San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Suzanne Thomas Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2023
Decision Date	03/22/2024
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