FilmArray Global Fever Panel External Control Kit

Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays

BioFire Defense, LLC

The following data is part of a premarket notification filed by Biofire Defense, Llc with the FDA for Filmarray Global Fever Panel External Control Kit.

Pre-market Notification Details

Device IDK202382
510k NumberK202382
Device Name:FilmArray Global Fever Panel External Control Kit
ClassificationAssayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Applicant BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City,  UT  84107
ContactCynthia Phillips
CorrespondentCynthia Phillips
BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City,  UT  84107
Product CodePMN  
CFR Regulation Number866.3920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-20
Decision Date2020-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851458005259 K202382 000

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