K813597 is an FDA 510(k) clearance for the TDX PRIMIDONE. This device is classified as a Enzyme Immunoassay, Primidone (Class II - Special Controls, product code DJD).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 22, 1982, 25 days after receiving the submission on December 28, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3680.
| 510(k) Number | K813597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1981 |
| Decision Date | January 22, 1982 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DJD — Enzyme Immunoassay, Primidone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3680 |