K853628 is an FDA 510(k) clearance for the SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY. This device is classified as a Radioimmunoassay, Free Thyroxine (Class II - Special Controls, product code CEC).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on September 18, 1985, 20 days after receiving the submission on August 29, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1695.
| 510(k) Number | K853628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1985 |
| Decision Date | September 18, 1985 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEC — Radioimmunoassay, Free Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1695 |