Psychemedics Microplate EIA for Fentanyl in Hair

Psychemedics Microplate EIA for Fentanyl in Hair is an FDA 510(k)-cleared medical device (K182103) manufactured by Psychemedics Corporation. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 17, 2019. Regulation: 8.