K833791 is an FDA 510(k) clearance for the SYVA ADVANCE DIGOXIN ASSAY. This device is classified as a Enzyme Immunoassay, Digoxin (Class II - Special Controls, product code KXT).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1984, 73 days after receiving the submission on October 31, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K833791 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 1983 |
| Decision Date | January 12, 1984 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KXT — Enzyme Immunoassay, Digoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |