K922433 is an FDA 510(k) clearance for the VISTA THYROXINE (T-4) ASSAY -- MODIFICATION. This device is classified as a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II - Special Controls, product code KLI).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on September 18, 1992, 155 days after receiving the submission on April 16, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K922433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 1992 |
| Decision Date | September 18, 1992 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |