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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 a medical device manufactured by Biofire Defense, LLC. It received FDA 510(k) clearance on 2020-11-20 under approval 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. It is manufactured by Biofire Defense, LLC. The 510(k) number is K202382.

When was FilmArray Global Fever Panel External Control Kit approved by the FDA?

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

What company makes FilmArray Global Fever Panel External Control Kit?

FilmArray Global Fever Panel External Control Kit is manufactured by Biofire Defense, LLC.

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.

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Other Devices by Biofire Defense, LLC

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Related Devices (Code: PMN)

K161573FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. K152679Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPakBio-Rad Laboratories DEN150058Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPakBio-Rad Laboratories K173171FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. K163522FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. K182472Cepheid Xpert GBS LB Control PanelMicrobiologics, 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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