FDA 510(k) Applications for Medical Device Product Code: PLO ()

FDA 510(k) Applications for Medical Device Product Code "PLO"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K160462	BIOFIRE DIAGNOSTICS, LLC	FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch	03/17/2016
DEN150013	BioFire Diagnostics, LLC	FilmArray Meningitis/Encephalitis(ME) Panel	10/08/2015
K190219	DiaSorin Molecular LLC	Simplexa VZV Direct, Simplexa VZV Positive Control Pack	05/13/2019