K780146 is an FDA 510(k) clearance for the T3 STI KIT. This device is classified as a Radioassay, Triiodothyronine Uptake (Class II - Special Controls, product code KHQ).
Submitted by Polysciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1978, 24 days after receiving the submission on January 30, 1978.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.1715.
| 510(k) Number | K780146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1978 |
| Decision Date | February 23, 1978 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | KHQ — Radioassay, Triiodothyronine Uptake |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1715 |