K925913 is an FDA 510(k) clearance for the ACCESS(R) FREE T4 ASSAY. This device is classified as a Radioimmunoassay, Free Thyroxine (Class II - Special Controls, product code CEC).
Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on January 27, 1993, 65 days after receiving the submission on November 23, 1992.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1695.
| 510(k) Number | K925913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1992 |
| Decision Date | January 27, 1993 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | CEC — Radioimmunoassay, Free Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1695 |