FDA 510(k) Application Details - K243518

Device Classification Name	More FDA Info for this Device
510(K) Number	K243518
Device Name	BinaxNOWÖ COVID-19 Antigen Self Test; BinaxNOWÖ COVID-19 Ag Card
Applicant	Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 US Other 510(k) Applications for this Company
Contact	Kristen Cyr 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	11/13/2024
Decision Date	02/11/2025
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