FDA 510(k) Application Details - K173927

Device Classification Name	More FDA Info for this Device
510(K) Number	K173927
Device Name	Elecsys BRAHMS PCT
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Wes Gerbig 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	12/26/2017
Decision Date	07/06/2018
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