K260787
- 510(k) number
- K260787
- Device name
- FebriDx Bacterial/Non-bacterial Assay
- Applicant
- Lumos Diagnostics, Inc. CA · US
- Product code
- QXA — Lateral Flow Immunochromatography Assay For Host Bio
- Decision date
- 2026-03-24
- Date received
- 2026-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260787.pdf
Official FDA record: K260787
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.