FilmArray Respiratory Panel EZ (RP EZ)

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 Ez (rp Ez).

Pre-market Notification Details

Device IDK152579
510k NumberK152579
Device Name:FilmArray Respiratory Panel EZ (RP EZ)
ClassificationRespiratory Virus Panel Nucleic Acid 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 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)
TypeDual Track
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-10
Decision Date2016-10-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815381020147 K152579 000

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