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FDA 510(k)

FilmArray Global Fever Panel External Control Kit

K-Number: K202382 · 2020-11-20

ApplicantBiofire Defense, LLC
Decision Date2020-11-20
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray Global Fever Panel External Control Kit is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Defense, LLC. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K202382. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FilmArray Global Fever Panel External Control Kit?

FilmArray Global Fever Panel External Control Kit is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Biofire Defense, LLC. The 510(k) number is K202382.

When did FilmArray Global Fever Panel External Control Kit receive FDA 510(k) clearance?

FilmArray Global Fever Panel External Control Kit received FDA 510(k) clearance on 2020-11-20, under 510(k) number K202382.

Who is the listed applicant for FilmArray Global Fever Panel External Control Kit?

The FDA 510(k) record lists Biofire Defense, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FilmArray Global Fever Panel External Control Kit?

The FDA product code for FilmArray Global Fever Panel External Control Kit is PMN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07221097Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other CoronavirusesCOMPLETED

Other records listing Biofire Defense, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitK243822BioFire Warrior Panel; BioFire Warrior Panel Control KitK213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens PanelK220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelK221460BioFire COVID-19 Test 2K211079BioFire COVID-19 Test 2

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Related Devices (Code: PMN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLCK260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc.K260041MDx-Chex for BCPStreck, LLCK254166MDx-Chex for BCNStreckK254167MDx-Chex for BCYStreck, LLCK251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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