FDA 510(k) Application Details - K250377

Device Classification Name	More FDA Info for this Device
510(K) Number	K250377
Device Name	Flowflex Plus COVID-19 + Flu A/B Home Test
Applicant	ACON Laboratories, Inc. 9440 Carroll Park Drive San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Catherine Shi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2025
Decision Date	05/10/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review