K132249 is an FDA 510(k) clearance for the ADVIA CENTAUR FT4, ADVIA CENTAUR T4. This device is classified as a Radioimmunoassay, Free Thyroxine (Class II - Special Controls, product code CEC).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on September 13, 2013, 56 days after receiving the submission on July 19, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1695.
| 510(k) Number | K132249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2013 |
| Decision Date | September 13, 2013 |
| Days to Decision | 56 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 |