510(k) K260787 ยท QXA Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
FebriDx Bacterial/Non-bacterial Assay
| Applicant | Lumos Diagnostics, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Mar 24, 2026 |
| Received | Mar 10, 2026 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K260787
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.