Psychemedics Corporation - FDA 510(k) Cleared Devices

Psychemedics Corporation, is a hair drug testing laboratory headquartered in Dallas, Texas, with a manufacturing facility in Culver City, California. The company pioneered commercially-available hair drug testing in 1986 and specializes in toxicology testing for substance detection.

Psychemedics has received 7 FDA 510(k) clearances from 7 total submissions between 2017 and 2022. All submissions focused on toxicology devices, including homogeneous enzyme immunoassay and microplate enzyme immunoassay systems for detecting drugs in hair samples.

The company's cleared devices target detection of amphetamines, cocaine, opiates, oxycodone, phencyclidine, cotinine, fentanyl, and benzodiazepines. Psychemedics holds nine patents in hair testing technology and has published extensive peer-reviewed research validating its methods.

Note: Psychemedics has not received FDA 510(k) clearances since 2022 and is considered inactive for regulatory purposes. This profile reflects the company's historical FDA clearance record. Explore the device database to review specific product names, predicate devices, and clearance dates.