K803075 is an FDA 510(k) clearance for the DIGOXIN RIABEAD DIAGNOSTIC KIT. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (Class II - Special Controls, product code DON).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 22, 1980, 17 days after receiving the submission on December 5, 1980.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K803075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1980 |
| Decision Date | December 22, 1980 |
| Days to Decision | 17 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 |