K833634 is an FDA 510(k) clearance for the EMIT & METHOFREXATE ASSAY. This device is classified as a Enzyme Immunoassay, Methotrexate.
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983, 66 days after receiving the submission on October 17, 1983.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K833634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1983 |
| Decision Date | December 22, 1983 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LAO — Enzyme Immunoassay, Methotrexate |
| Device Class | — |