510(k) K182103

Psychemedics Microplate EIA for Fentanyl in Hair by Psychemedics Corporation — Product Code DJG

K182103 is an FDA 510(k) premarket notification submitted by Psychemedics Corporation for the device "Psychemedics Microplate EIA for Fentanyl in Hair". The FDA issued a decision of Substantially Equivalent on April 18, 2019. 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.