K792153 is an FDA 510(k) clearance for the DIGOXIN RADIOIMMUNOASSAY SYSTEM. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. (Class II - Special Controls, product code DPB).
Submitted by Radioimmunoassay, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979, 18 days after receiving the submission on October 26, 1979.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K792153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1979 |
| Decision Date | November 13, 1979 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DPB — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |