K233454 is an FDA 510(k) clearance for the ONLINE TDM Methotrexate. This device is classified as a Enzyme Immunoassay, Methotrexate.
Submitted by Roche Diagnostics Operations (Indianapolis, US). The FDA issued a Cleared decision on February 20, 2024, 123 days after receiving the submission on October 20, 2023.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K233454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2023 |
| Decision Date | February 20, 2024 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LAO — Enzyme Immunoassay, Methotrexate |
| Device Class | — |