K901475 is an FDA 510(k) clearance for the CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4. This device is classified as a Radioimmunoassay, Total Thyroxine (Class II - Special Controls, product code CDX).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on June 20, 1990, 85 days after receiving the submission on March 27, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K901475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1990 |
| Decision Date | June 20, 1990 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDX — Radioimmunoassay, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |