K802615 is an FDA 510(k) clearance for the EMIT-STM OPIATE ASSAY. This device is classified as a Thin Layer Chromatography, Salicylate (Class II - Special Controls, product code DJE).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980, 11 days after receiving the submission on October 20, 1980.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3830.
| 510(k) Number | K802615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1980 |
| Decision Date | October 31, 1980 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DJE — Thin Layer Chromatography, Salicylate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3830 |