K833581 is an FDA 510(k) clearance for the MODIF. OF EMIT URINE OPIATE ASSAY. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1984, 106 days after receiving the submission on October 12, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K833581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1983 |
| Decision Date | January 26, 1984 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |