K232017 is an FDA 510(k) clearance for the ARK Methotrexate II Assay. This device is classified as a Enzyme Immunoassay, Methotrexate.
Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on December 20, 2023, 166 days after receiving the submission on July 7, 2023.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K232017 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2023 |
| Decision Date | December 20, 2023 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LAO - Enzyme Immunoassay, Methotrexate |
| Device Class | - |