Source document or public record
FDA 510(k) K212727 — FilmArray Pneumonia Panel
FDA 510(k) index record K212727. Device: FilmArray Pneumonia Panel. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2021-09-22.
Source
"device_name": "FilmArray Pneumonia Panel"
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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2026-10-20
2026-10-20
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FDA 510(k) public index record K212727.
Device name: FilmArray Pneumonia Panel. Applicant as listed: Biofire Diagnostics, LLC.
Decision date: 2021-09-22. Decision wording: Substantially Equivalent.
Product code: QDP. Regulation: 21 CFR 866.3985. Medical specialty: Microbiology.
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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