K152227 is an FDA 510(k) clearance for the Elecsys Cortisol II, Cortisol II CalSet. This device is classified as a Fluorometric, Cortisol (Class II - Special Controls, product code JFT).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 27, 2016, 264 days after receiving the submission on August 7, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1205.
| 510(k) Number | K152227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2015 |
| Decision Date | April 27, 2016 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFT — Fluorometric, Cortisol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1205 |