K131244 is an FDA 510(k) clearance for the ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET. 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 January 27, 2014, 271 days after receiving the submission on May 1, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1695.
| 510(k) Number | K131244 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2013 |
| Decision Date | January 27, 2014 |
| Days to Decision | 271 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 |