FDA 510(k) Application Details - K230236

Device Classification Name	More FDA Info for this Device
510(K) Number	K230236
Device Name	Lyra Influenza A+B Assay
Applicant	Quidel Corporation 10165 McKellar Court San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Selena Liu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/2023
Decision Date	03/03/2023
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