510(k) K201326

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair by Psychemedics Corporation — Product Code DJG

K201326 is an FDA 510(k) premarket notification submitted by Psychemedics Corporation for the device "Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair". The FDA issued a decision of Substantially Equivalent on July 27, 2021. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Psychemedics Corporation has at least 6 other 510(k) clearances on record.