K923676 is an FDA 510(k) clearance for the VISTA THYROXINE UPTAKE ASSAY. This device is classified as a Radioassay, Triiodothyronine Uptake (Class II - Special Controls, product code KHQ).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on October 9, 1992, 79 days after receiving the submission on July 22, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1715.
| 510(k) Number | K923676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1992 |
| Decision Date | October 09, 1992 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KHQ — Radioassay, Triiodothyronine Uptake |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1715 |