K840461 is an FDA 510(k) clearance for the MAGIC 125I DIGOXIN RADIOIMMUNOASSAY. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (Class II - Special Controls, product code DON).
Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984, 50 days after receiving the submission on February 2, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K840461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1984 |
| Decision Date | March 23, 1984 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DON — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |