K821811 is an FDA 510(k) clearance for the 125I DIGOXIN RADIOIMMUNOASSAY KIT. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. (Class II - Special Controls, product code DPB).
Submitted by Cambridge Medical Technology (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982, 14 days after receiving the submission on June 18, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K821811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1982 |
| Decision Date | July 02, 1982 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DPB — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |