Quest Diagnostics HairCheck-DT (Cocaine)

Quest Diagnostics HairCheck-DT (Cocaine) is an FDA 510(k)-cleared medical device (K152232) manufactured by Quest Diagnostics Incorporated. 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 November 17, 2016. Regulation: 8.