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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 the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2021-09-22 under 510(k) 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. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K212727.

When did FilmArray Pneumonia Panel receive FDA 510(k) clearance?

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

Who is the listed applicant for FilmArray Pneumonia Panel?

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

What is the FDA product code for FilmArray Pneumonia Panel?

The FDA product code for FilmArray Pneumonia Panel is QDP.

Other records listing Biofire Diagnostics, 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.

K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniK243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidK243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelK241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniK232954BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

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Related Devices (Code: QDP)

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.

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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