FDA 510(k) Application Details - K230956

Device Classification Name	More FDA Info for this Device
510(K) Number	K230956
Device Name	BD Respiratory Viral Panel for BD MAXÖ System; BD Respiratory Viral Panel-SCV2 for BD MAXÖ System
Applicant	BD Integrated Diagnostic Solutions/ Becton, Dickinson & Company 7 Loveton Circle Sparks, MD 21152 US Other 510(k) Applications for this Company
Contact	Kathy Barnecut 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	04/04/2023
Decision Date	07/31/2023
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