Source document or public record
FDA 510(k) K243463 — BIOFIRE FILMARRAY Tropical Fever Panel
FDA 510(k) index record K243463. Device: BIOFIRE FILMARRAY Tropical Fever Panel. Applicant as listed: Biofire Diagnostics, LLC (Biomerieux). Decision date: 2024-12-05.
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"device_name": "BIOFIRE FILMARRAY Tropical Fever 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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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K243463.
Device name: BIOFIRE FILMARRAY Tropical Fever Panel. Applicant as listed: Biofire Diagnostics, LLC (Biomerieux).
Decision date: 2024-12-05. Decision wording: Substantially Equivalent.
Product code: QMV. Regulation: 21 CFR 866.3966. 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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