K111904 is an FDA 510(k) clearance for the ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN. This device is classified as a Enzyme Immunoassay, Methotrexate.
Submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 18, 2011, 105 days after receiving the submission on July 5, 2011.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K111904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2011 |
| Decision Date | October 18, 2011 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LAO - Enzyme Immunoassay, Methotrexate |
| Device Class | - |