K830683 is an FDA 510(k) clearance for the TDX THYROXINE. This device is classified as a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II - Special Controls, product code KLI).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 6, 1983, 33 days after receiving the submission on March 4, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K830683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1983 |
| Decision Date | April 06, 1983 |
| Days to Decision | 33 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 |