510(k) K201228

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair by Psychemedics Corporation — Product Code JXO

K201228 is an FDA 510(k) premarket notification submitted by Psychemedics Corporation for the device "Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair". The FDA issued a decision of Substantially Equivalent on June 25, 2021. The device falls under product code JXO (Enzyme Immunoassay, Cocaine), a Class II device regulated under 21 CFR 862.3250. Psychemedics Corporation has at least 6 other 510(k) clearances on record.