Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair is an FDA 510(k)-cleared medical device (K201228) manufactured by Psychemedics Corporation. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 24, 2021. Regulation: 8.