K904816 is an FDA 510(k) clearance for the THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM. This device is classified as a Radioimmunoassay, Total Thyroxine (Class II - Special Controls, product code CDX).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on January 17, 1991, 85 days after receiving the submission on October 24, 1990.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K904816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 1990 |
| Decision Date | January 17, 1991 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | CDX — Radioimmunoassay, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |