K181233 is an FDA 510(k) clearance for the Elecsys FT4 III. 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 September 18, 2018, 132 days after receiving the submission on May 9, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1695.
| 510(k) Number | K181233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2018 |
| Decision Date | September 18, 2018 |
| Days to Decision | 132 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 |