K770474 is an FDA 510(k) clearance for the THYROSCREEN TM T4 DIAGNOSTIC KIT. 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 April 28, 1977, 48 days after receiving the submission on March 11, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K770474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1977 |
| Decision Date | April 28, 1977 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CDX — Radioimmunoassay, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |