FDA 510(k) Application Details - K173683

Device Classification Name	More FDA Info for this Device
510(K) Number	K173683
Device Name	LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
Applicant	DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082-0285 US Other 510(k) Applications for this Company
Contact	John C Walter Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PRI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/2017
Decision Date	02/27/2018
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