FilmArray Pneumonia Panel

Lower Respiratory Microbial 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 Pneumonia Panel.

Pre-market Notification Details

Device IDK180966
510k NumberK180966
Device Name:FilmArray Pneumonia Panel
ClassificationLower Respiratory Microbial Nucleic Acid Detection System
Applicant BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City,  UT  84108
ContactKristen J. Kanack
CorrespondentKristen J. Kanack
BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City,  UT  84108
Product CodeQBH  
CFR Regulation Number866.3985 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-13
Decision Date2018-11-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815381020185 K180966 000
00815381020178 K180966 000

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