K771638 is an FDA 510(k) clearance for the IGOXIN SOLID PHASE RIA. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. (Class II - Special Controls, product code DPO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 7, 1977, 42 days after receiving the submission on August 26, 1977.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K771638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1977 |
| Decision Date | October 07, 1977 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DPO — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |