K842196 is an FDA 510(k) clearance for the STRATUS PRIMIDONE FLOROMETRIC ENZY. This device is classified as a Fluorescent Immunoassay, Primidone (Class II - Special Controls, product code LFT).
Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on July 11, 1984, 37 days after receiving the submission on June 4, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3680.
| 510(k) Number | K842196 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1984 |
| Decision Date | July 11, 1984 |
| Days to Decision | 37 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 |