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FDA 510(k)

FilmArray Pneumonia Panel

K-Number: K212727 · 2021-09-22

ApplicantBiofire Diagnostics, LLC
Decision Date2021-09-22
Product CodeQDP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray Pneumonia Panel is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2021-09-22 under approval number K212727. The device is classified under product code QDP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FilmArray Pneumonia Panel?

FilmArray Pneumonia Panel is a medical device that received FDA 510(k) clearance on 2021-09-22. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K212727.

When was FilmArray Pneumonia Panel approved by the FDA?

FilmArray Pneumonia Panel received FDA 510(k) clearance on 2021-09-22, under approval number K212727.

What company makes FilmArray Pneumonia Panel?

FilmArray Pneumonia Panel is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for FilmArray Pneumonia Panel?

The FDA product code for FilmArray Pneumonia Panel is QDP.

Other Devices by Biofire Diagnostics, LLC

K152579FilmArray Respiratory Panel EZ (RP EZ) K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch K160462FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch K160068FilmArray Respiratory Panel (RP) for use with FilmArray Torch DEN170017FilmArray Respiratory Panel 2 plus (RP2plus)

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Related Devices (Code: QDP)

K180966FilmArray Pneumonia PanelBiofire Diagnostics, LLC

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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