510(k) K163590

Psychemedics Microplate EIA for Benzodiazepines in Hair by Psychemedics Corporation — Product Code JXM

K163590 is an FDA 510(k) premarket notification submitted by Psychemedics Corporation for the device "Psychemedics Microplate EIA for Benzodiazepines in Hair". The FDA issued a decision of Substantially Equivalent on September 15, 2017. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Psychemedics Corporation has at least 6 other 510(k) clearances on record.