510(k) K212952

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair by Psychemedics Corporation — Product Code LCM

K212952 is an FDA 510(k) premarket notification submitted by Psychemedics Corporation for the device "Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair". The FDA issued a decision of Substantially Equivalent on April 18, 2022. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Psychemedics Corporation has at least 6 other 510(k) clearances on record.