FDA 510(k) Application Details - K173171

Device Classification Name	More FDA Info for this Device
510(K) Number	K173171
Device Name	FilmArray RP2/RP2plus Control Panel
Applicant	Maine Molecular Quality Controls, Inc. 23 Mill Brook Road Saco, ME 04072 US Other 510(k) Applications for this Company
Contact	Joan Gordon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2017
Decision Date	11/24/2017
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