FDA 510(k) Application Details - K181412

Device Classification Name	More FDA Info for this Device
510(K) Number	K181412
Device Name	VITEK MS
Applicant	bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 US Other 510(k) Applications for this Company
Contact	Jennifer Jines Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2018
Decision Date	12/21/2018
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