Source document or public record
FDA 510(k) K260787 — FebriDx Bacterial/Non-bacterial Assay
FDA 510(k) index record K260787. Device: FebriDx Bacterial/Non-bacterial Assay. Applicant as listed: Lumos Diagnostics, Inc.. Decision date: 2026-03-24.
Source
"device_name": "FebriDx Bacterial/Non-bacterial Assay"
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 K260787.
Device name: FebriDx Bacterial/Non-bacterial Assay. Applicant as listed: Lumos Diagnostics, Inc..
Decision date: 2026-03-24. Decision wording: Substantially Equivalent.
Product code: QXA. Regulation: 21 CFR 866.3230. 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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