FDA 510(k) Application Details - K190222

Device Classification Name	More FDA Info for this Device
510(K) Number	K190222
Device Name	FilmArray Pneumonia/Pneumoniaplus Control
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	02/05/2019
Decision Date	05/03/2019
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