K802841 is an FDA 510(k) clearance for the DIGOXIN RADIOIMMUNOASSAY KIT. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. (Class II - Special Controls, product code DNL).
Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980, 36 days after receiving the submission on November 12, 1980.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K802841 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1980 |
| Decision Date | December 18, 1980 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DNL — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |