K840939 is an FDA 510(k) clearance for the EMIT QST PRIMIDONE ASSAY. This device is classified as a Enzyme Immunoassay, Primidone (Class II - Special Controls, product code DJD).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1984, 50 days after receiving the submission on March 5, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3680.
| 510(k) Number | K840939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1984 |
| Decision Date | April 24, 1984 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DJD — Enzyme Immunoassay, Primidone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3680 |