K820138 is an FDA 510(k) clearance for the PRIMIDONE REAGENT TEST KIT. This device is classified as a Enzyme Immunoassay, Primidone (Class II - Special Controls, product code DJD).
Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1982, 10 days after receiving the submission on January 18, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3680.
| 510(k) Number | K820138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 1982 |
| Decision Date | January 28, 1982 |
| Days to Decision | 10 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 |