FDA 510(k) Application Details - K222736

Device Classification Name	More FDA Info for this Device
510(K) Number	K222736
Device Name	Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Applicant	Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Vlada Rudenko Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2022
Decision Date	05/16/2023
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