FilmArray Respiratory Panel (RP) For Use With Multi-instrument FilmArray System

Respiratory Virus Panel Nucleic Acid Assay System

BioFire Diagnostics, LLC

The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Respiratory Panel (rp) For Use With Multi-instrument Filmarray System.

Pre-market Notification Details

Device IDK143080
510k NumberK143080
Device Name:FilmArray Respiratory Panel (RP) For Use With Multi-instrument FilmArray System
ClassificationRespiratory Virus Panel Nucleic Acid Assay System
Applicant BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City,  UT  84108
ContactKristen Kanack
CorrespondentKristen Kanack
BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City,  UT  84108
Product CodeOCC  
Subsequent Product CodeOEM
Subsequent Product CodeOEP
Subsequent Product CodeOOI
Subsequent Product CodeOOU
Subsequent Product CodeOQW
Subsequent Product CodeOTG
Subsequent Product CodeOZX
Subsequent Product CodeOZY
Subsequent Product CodeOZZ
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-27
Decision Date2015-02-17
Summary:summary

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