K163359 is an FDA 510(k) clearance for the ARK Methotrexate Assay. This device is classified as a Enzyme Immunoassay, Methotrexate.
Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on August 18, 2017, 261 days after receiving the submission on November 30, 2016.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K163359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2016 |
| Decision Date | August 18, 2017 |
| Days to Decision | 261 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LAO - Enzyme Immunoassay, Methotrexate |
| Device Class | - |