K810586 is an FDA 510(k) clearance for the EMIT-TFG PRISMA THYROXINE ASSAY. This device is classified as a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II - Special Controls, product code KLI).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1981, 13 days after receiving the submission on March 4, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K810586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1981 |
| Decision Date | March 17, 1981 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |