K803045 is an FDA 510(k) clearance for the IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol (Class II - Special Controls, product code DOG).
Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980, 21 days after receiving the submission on December 1, 1980.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K803045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1980 |
| Decision Date | December 22, 1980 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DOG — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |