K823265 is an FDA 510(k) clearance for the MONOCLONAL ANTIBODY T4 RADIO-KIT. 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 December 9, 1982, 37 days after receiving the submission on November 2, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K823265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1982 |
| Decision Date | December 09, 1982 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDX — Radioimmunoassay, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |