FDA 510(k) Application Details - K181368

Device Classification Name	Susceptibility Test Plate, Antifungal   More FDA Info for this Device
510(K) Number	K181368
Device Name	Susceptibility Test Plate, Antifungal
Applicant	bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 US Other 510(k) Applications for this Company
Contact	Jolyn Tenllado Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	NGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2018
Decision Date	06/20/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review