K780292 is an FDA 510(k) clearance for the TRIA-PEG RIA DIAG. KIT. This device is classified as a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP).
Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1978, 9 days after receiving the submission on February 21, 1978.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1710.
| 510(k) Number | K780292 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1978 |
| Decision Date | March 02, 1978 |
| Days to Decision | 9 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 |