K202136 is an FDA 510(k) clearance for the IDS Cortisol. This device is classified as a Radioimmunoassay, Cortisol (Class II - Special Controls, product code CGR).
Submitted by Immunodiagnostic Systems , Ltd. (Boldon, GB). The FDA issued a Cleared decision on April 13, 2021, 256 days after receiving the submission on July 31, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1205.
| 510(k) Number | K202136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2020 |
| Decision Date | April 13, 2021 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGR — Radioimmunoassay, Cortisol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1205 |