FDA 510(k) Application Details - K191957

Device Classification Name	More FDA Info for this Device
510(K) Number	K191957
Device Name	BD MAX Vaginal Panel
Applicant	GeneOhm Sciences Canada, Inc. (BD Diagnostics) 2555 Boul. du Parc-Technologique Quebec GIP 4S5 CA Other 510(k) Applications for this Company
Contact	Katie Edwards 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	07/23/2019
Decision Date	10/21/2019
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