K792484 is an FDA 510(k) clearance for the TIPSEP-T3U TRIIODOTHYRONINE UPTAKE. This device is classified as a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ).
Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1979, 24 days after receiving the submission on December 3, 1979.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1715.
| 510(k) Number | K792484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1979 |
| Decision Date | December 27, 1979 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KHQ — Radioassay, Triiodothyronine Uptake |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1715 |