K772098 is an FDA 510(k) clearance for the DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (Class II - Special Controls, product code DON).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 20, 1977, 43 days after receiving the submission on November 7, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K772098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1977 |
| Decision Date | December 20, 1977 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DON — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |