FDA 510(k) Application Details - K172412

Device Classification Name	More FDA Info for this Device
510(K) Number	K172412
Device Name	BacterioScan 216Dx System
Applicant	BacterioScan, Inc. 4041 Forest Park Ave. St. Louis, MO 63108 US Other 510(k) Applications for this Company
Contact	Rhonda Soest Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2017
Decision Date	05/01/2018
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