K202826 is an FDA 510(k) clearance for the IMMULITE® 2000 Cortisol. This device is classified as a Radioimmunoassay, Cortisol (Class II - Special Controls, product code CGR).
Submitted by Siemens Healthcare Diagnostics Products, Ltd. (Caerarfon, GB). The FDA issued a Cleared decision on January 15, 2021, 113 days after receiving the submission on September 24, 2020.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1205.
| 510(k) Number | K202826 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2020 |
| Decision Date | January 15, 2021 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | CGR — Radioimmunoassay, Cortisol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1205 |