FDA 510(k) Application Details - K243872

Device Classification Name	More FDA Info for this Device
510(K) Number	K243872
Device Name	BD Veritor System for SARS-CoV-2
Applicant	Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 US Other 510(k) Applications for this Company
Contact	Thi My Lan Dang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2024
Decision Date	06/16/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review