K790602 is an FDA 510(k) clearance for the RIA, DIGNXIN-125-I. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. (Class II - Special Controls, product code DPB).
Submitted by Endocrine-Metabolic Center (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979, 125 days after receiving the submission on March 27, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K790602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1979 |
| Decision Date | July 30, 1979 |
| Days to Decision | 125 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 |