FDA 510(k) Application Details - K214122

Device Classification Name	More FDA Info for this Device
510(K) Number	K214122
Device Name	BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
Applicant	Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 US Other 510(k) Applications for this Company
Contact	Joseph Basore Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2021
Decision Date	07/28/2022
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