K220456 is an FDA 510(k) clearance for the Elecsys FT4 IV. This device is classified as a Radioimmunoassay, Free Thyroxine (Class II - Special Controls, product code CEC).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 7, 2023, 414 days after receiving the submission on February 17, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1695.
| 510(k) Number | K220456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2022 |
| Decision Date | April 07, 2023 |
| Days to Decision | 414 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CEC — Radioimmunoassay, Free Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1695 |