FDA 510(k) Application Details - K181427

Device Classification Name	More FDA Info for this Device
510(K) Number	K181427
Device Name	BD MAX Enteric Viral Panel, BD MAX Instrument
Applicant	Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 US Other 510(k) Applications for this Company
Contact	Laura Stewart Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2018
Decision Date	11/29/2018
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