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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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