FDA 510(k) Application Details - K230917

Device Classification Name	More FDA Info for this Device
510(K) Number	K230917
Device Name	FebriDx Bacterial / Non-bacterial Point of Care Assay
Applicant	Lumos Diagnostics, Inc. 2724 Loker Avenue Carlsbad, CA 92010 US Other 510(k) Applications for this Company
Contact	Sue Hibbeln Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2023
Decision Date	06/30/2023
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