K822229 is an FDA 510(k) clearance for the PRIMIDONE FLUORESCENT IMMUNOASSAY. This device is classified as a Fluorescent Immunoassay, Primidone (Class II - Special Controls, product code LFT).
Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1982, 16 days after receiving the submission on July 27, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3680.
| 510(k) Number | K822229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1982 |
| Decision Date | August 12, 1982 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LFT — Fluorescent Immunoassay, Primidone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3680 |