FebriDx Bacterial/Non-bacterial Assay— 510(k) K260787

Name: FDA 510(k) clearance K260787
Creator: U.S. Food and Drug Administration
Published: 2026-03-24

Substantially Equivalent

Lumos Diagnostics, Inc.

FDA 510(k) clearance K260787 for FebriDx Bacterial/Non-bacterial Assay, Substantially Equivalent on 2026-03-24. Applicant: Lumos Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Lumos Diagnostics, Inc.
Product code: Code QXA
Device class: Class 2
Regulation: 21 CFR 866.3230
Advisory panel: Microbiology
Date received: 2026-03-10
Decision date: 2026-03-24
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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