510(k) K230917 ยท QXA Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
FebriDx Bacterial / Non-bacterial Point of Care Assay
| Applicant | Lumos Diagnostics, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 30, 2023 |
| Received | Apr 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230917
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.