IBL CORTISOL LIA TEST KIT

IBL CORTISOL LIA TEST KIT is an FDA 510(k)-cleared medical device (K052359) manufactured by Lehnus & Associates Consulting. 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 October 2, 2005. Regulation: 8.