FilmArray Pneumonia Panel Plus

Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative 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 Pneumonia Panel Plus.

Pre-market Notification Details

Device IDK181324
510k NumberK181324
Device Name:FilmArray Pneumonia Panel Plus
ClassificationMers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex 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 CodeQDS  
CFR Regulation Number866.4001 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-18
Decision Date2018-11-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815381020321 K181324 000
00815381020314 K181324 000

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