FDA 510(k) Applications Submitted by Psychemedics Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K210212 01/27/2021 Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair Psychemedics Corporation
K201228 05/07/2020 Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair Psychemedics Corporation
K201326 05/19/2020 Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair Psychemedics Corporation
K212952 09/16/2021 Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair Psychemedics Corporation
K182103 08/03/2018 Psychemedics Microplate EIA for Fentanyl in Hair Psychemedics Corporation
K192517 09/13/2019 Psychemedics Microplate EIA for Cotinine in Hair Psychemedics Corporation
K163590 12/20/2016 Psychemedics Microplate EIA for Benzodiazepines in Hair Psychemedics Corporation


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