K833578 is an FDA 510(k) clearance for the MODIF. OF EMIT URINE BENZODIAZEPINE. This device is classified as a Enzyme Immunoassay, Benzodiazepine (Class II - Special Controls, product code JXM).
Submitted by Syva Co. (Walker, 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 862.3170.
| 510(k) Number | K833578 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 | JXM — Enzyme Immunoassay, Benzodiazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3170 |