K932912 is an FDA 510(k) clearance for the STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC. This device is classified as a Radioimmunoassay, Free Thyroxine (Class II - Special Controls, product code CEC).
Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on October 28, 1993, 134 days after receiving the submission on June 16, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1695.
| 510(k) Number | K932912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 1993 |
| Decision Date | October 28, 1993 |
| Days to Decision | 134 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 |