FilmArray Gastrointestinal Panel (GI) For Use With FilmArray Torch

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System

BIOFIRE DIAGNOSTICS, LLC

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

Pre-market Notification Details

Device IDK160459
510k NumberK160459
Device Name:FilmArray Gastrointestinal Panel (GI) For Use With FilmArray Torch
ClassificationGastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay 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 CodePCH  
CFR Regulation Number866.3990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-19
Decision Date2016-04-01
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.