Medical Device Manufacturer · US , Culver City , CA

Psychemedics Corporation

7 submissions · 7 cleared · Since 2017
7
Total
7
Cleared
0
Denied

Psychemedics Corporation — FDA 510(k) Submissions

Psychemedics Corporation has submitted 7 FDA 510(k) premarket notifications since 2017, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Benzodiazepine, Enzyme Immunoassay, Nicotine And Nicotine Metabolites, Enzyme Immunoassay, Cocaine, Gas Chromatography, Methamphetamine . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
K212952 · LCM Enzyme Immunoassay,... · Toxicology
Apr 2022 214d
Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
K210212 · LAF Gas Chromatography,... · Toxicology
Dec 2021 322d
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
K201326 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jul 2021 434d
Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
K201228 · JXO Enzyme Immunoassay, Cocaine · Toxicology
Jun 2021 414d
Psychemedics Microplate EIA for Cotinine in Hair
K192517 · MKU Enzyme Immunoassay,... · Toxicology
Apr 2020 222d
Psychemedics Microplate EIA for Fentanyl in Hair
K182103 · DJG Enzyme Immunoassay, Opiates · Toxicology
Apr 2019 258d
Psychemedics Microplate EIA for Benzodiazepines in Hair
K163590 · JXM Enzyme Immunoassay,... · Toxicology
Sep 2017 269d
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