K820154 is an FDA 510(k) clearance for the TDX DIGOXIN. This device is classified as a Radioimmunoassay, Digoxin (125-i) (Class II - Special Controls, product code LCS).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 5, 1982, 17 days after receiving the submission on January 19, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K820154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1982 |
| Decision Date | February 05, 1982 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCS — Radioimmunoassay, Digoxin (125-i) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |