K800246 is an FDA 510(k) clearance for the EMIT -D.A.U. CANNABINOID URINE ASSAY. This device is classified as a Radioimmunoassay, Cannabinoid(s) (Class II - Special Controls, product code LAT).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1980, 21 days after receiving the submission on February 5, 1980.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K800246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1980 |
| Decision Date | February 26, 1980 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LAT — Radioimmunoassay, Cannabinoid(s) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |