K822592 is an FDA 510(k) clearance for the ADVANCE TM T-3 UPTAKE ASSAY. This device is classified as a Radioassay, Triiodothyronine Uptake (Class II - Special Controls, product code KHQ).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 8, 1982, 31 days after receiving the submission on September 7, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1715.
| 510(k) Number | K822592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1982 |
| Decision Date | October 08, 1982 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KHQ — Radioassay, Triiodothyronine Uptake |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1715 |