Culver City, CA, US · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | Unclassified | Unknown | 1 | 2022-04-18 |
| LAF | Gas Chromatography, Methamphetamine | Class II | Clinical Toxicology | 1 | 2021-12-15 |
| DJG | Enzyme Immunoassay, Opiates | Class II | Clinical Toxicology | 1 | 2021-07-27 |
| JXO | Enzyme Immunoassay, Cocaine | Class II | Clinical Toxicology | 1 | 2021-06-25 |
| MKU | Enzyme Immunoassay, Nicotine And Nicotine Metabolites | Class I | Clinical Toxicology | 1 | 2020-04-22 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2022-04-18 | K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | LCM | Unclassified | Unknown |
| 2021-12-15 | K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | LAF | Class II | Clinical Toxicology |
| 2021-07-27 | K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair | DJG | Class II | Clinical Toxicology |
| 2021-06-25 | K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair | JXO | Class II | Clinical Toxicology |
| 2020-04-22 | K192517 | Psychemedics Microplate EIA for Cotinine in Hair | MKU | Class I | Clinical Toxicology |