Documento fuente o registro público
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.
Fuente
"device_name": "FilmArray Pneumonia Panel plus"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-30
professional use
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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