Psychemedics Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | April 18, 2022 |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | December 15, 2021 |
| K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enz | July 27, 2021 |
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair | June 25, 2021 |
| K192517 | Psychemedics Microplate EIA for Cotinine in Hair | April 22, 2020 |
| K182103 | Psychemedics Microplate EIA for Fentanyl in Hair | April 18, 2019 |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in Hair | September 15, 2017 |