Source document or public record
FDA 510(k) K222601 — FilmArray Pneumonia Panel plus
FDA 510(k) index record K222601. Device: FilmArray Pneumonia Panel plus. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2022-10-27.
Source
"device_name": "FilmArray Pneumonia Panel plus"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K222601.
Device name: FilmArray Pneumonia Panel plus. Applicant as listed: Biofire Diagnostics, LLC.
Decision date: 2022-10-27. Decision wording: Substantially Equivalent.
Product code: QDS. Regulation: 21 CFR 866.4001. Medical specialty: Pathology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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