K925109 is an FDA 510(k) clearance for the ABBOTT TDX/TDXFLX TT4. This device is classified as a Radioimmunoassay, Total Thyroxine (Class II - Special Controls, product code CDX).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 4, 1993, 87 days after receiving the submission on October 9, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K925109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1992 |
| Decision Date | January 04, 1993 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDX — Radioimmunoassay, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |