K833932 is an FDA 510(k) clearance for the SYVA ADVANCE CORTISOL ASSAY. This device is classified as a Fluorometric, Cortisol (Class II - Special Controls, product code JFT).
Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on December 29, 1983, 45 days after receiving the submission on November 14, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1205.
| 510(k) Number | K833932 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1983 |
| Decision Date | December 29, 1983 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JFT — Fluorometric, Cortisol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1205 |