FilmArray Meningitis/Encephalitis (ME) Panel For Use With FilmArray Torch

Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System

BIOFIRE DIAGNOSTICS, LLC

The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Meningitis/encephalitis (me) Panel For Use With Filmarray Torch.

Pre-market Notification Details

Device IDK160462
510k NumberK160462
Device Name:FilmArray Meningitis/Encephalitis (ME) Panel For Use With FilmArray Torch
ClassificationMeningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
Applicant BIOFIRE DIAGNOSTICS, LLC 390 WAKARA WAY Salt Lake City,  UT  84108
ContactKristen J. Kanack
CorrespondentKristen J. Kanack
BIOFIRE DIAGNOSTICS, LLC 390 WAKARA WAY Salt Lake City,  UT  84108
Product CodePLO  
CFR Regulation Number866.3970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-19
Decision Date2016-03-17
Summary:summary

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