510(k) K233454 ยท LAO Enzyme Immunoassay, Methotrexate
ONLINE TDM Methotrexate
| Applicant | Roche Diagnostics Operations, Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 20, 2024 |
| Received | Oct 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233454
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.