FDA 510(k) Application Details - K191766

Device Classification Name	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation   More FDA Info for this Device
510(K) Number	K191766
Device Name	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant	bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 US Other 510(k) Applications for this Company
Contact	Esther Hernandez Other 510(k) Applications for this Contact
Regulation Number	866.1645   More FDA Info for this Regulation Number
Classification Product Code	LON Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2019
Decision Date	08/05/2019
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