K771236 is an FDA 510(k) clearance for the TRIOBEAD-125 DIAGNOSTIC KIT. This device is classified as a Radioimmunoassay, Free Thyroxine (Class II - Special Controls, product code CEC).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 3, 1977, 23 days after receiving the submission on July 11, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1695.
| 510(k) Number | K771236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 1977 |
| Decision Date | August 03, 1977 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CEC — Radioimmunoassay, Free Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1695 |