LAO
- Product code
- LAO
- Device name
- Enzyme Immunoassay, Methotrexate
- Device class
- Class U
- Medical specialty
- Unknown
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 10 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233454 | 2024-02-20 | Roche Diagnostics Operations | ONLINE TDM Methotrexate | |
| K232017 | 2023-12-20 | Ark Diagnostics, Inc. | ARK Methotrexate II Assay |
Official FDA classification page: LAO
Classification and pathway per current FDA publications. Data from openFDA (CC0).