FDA 510(k) Application Details - DEN160001

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160001
Device Name	BD MAX Vaginal Panel, BD MAX Instrument
Applicant	GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS) 2555 BOUL. DE PARC-TECHNOLOGIQUE QUEBEC GIP 4S5 CA Other 510(k) Applications for this Company
Contact	MANON RICHARD Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/2016
Decision Date	10/28/2016
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review