Elecsys Cortisol II, Cortisol II CalSet

Elecsys Cortisol II, Cortisol II CalSet is an FDA 510(k)-cleared medical device (K152227) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 26, 2016. Regulation: 8.