K770201 is an FDA 510(k) clearance for the T3 RIA (PEG) DIAGNOSTIC KIT. This device is classified as a Radioimmunoassay, Total Triiodothyronine (Class II - Special Controls, product code CDP).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 5, 1977, 64 days after receiving the submission on January 31, 1977.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1710.
| 510(k) Number | K770201 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 1977 |
| Decision Date | April 05, 1977 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | CDP — Radioimmunoassay, Total Triiodothyronine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1710 |