FDA 510(k) Application Details - K163042

Device Classification Name	More FDA Info for this Device
510(K) Number	K163042
Device Name	chromID Strepto B agar
Applicant	bioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 US Other 510(k) Applications for this Company
Contact	Karen Russell Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2016
Decision Date	01/27/2017
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