K770733 is an FDA 510(k) clearance for the REAGENT SYSTEM, THYROXINE, ARIA. This device is classified as a Radioimmunoassay, Total Thyroxine (Class II - Special Controls, product code CDX).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on June 24, 1977, 65 days after receiving the submission on April 20, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K770733 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1977 |
| Decision Date | June 24, 1977 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CDX — Radioimmunoassay, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |