Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair

About This 510(k) Submission

K201326 is an FDA 510(k) clearance for the Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on July 27, 2021, 434 days after receiving the submission on May 19, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.