Company ยท US
Psychemedics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2022. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 5 |
| JXO | Enzyme Immunoassay, Cocaine | 2 |
| LAF | Gas Chromatography, Methamphetamine | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | 2 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 |
| KLN | Radioimmunoassay, Cocaine Metabolite | 1 |
| LAT | Radioimmunoassay, Cannabinoid(S) | 1 |
| LCL | Radioimmunoassay, Phencyclidine | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 |
| MKU | Enzyme Immunoassay, Nicotine And Nicotine Metabolites | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 18, 2022 | K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair Psychemedics Corporation | LCM |
| Dec 15, 2021 | K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair Psychemedics Corporation | LAF |
| Jul 27, 2021 | K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEI Psychemedics Corporation | DJG |
| Jun 25, 2021 | K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair Psychemedics Corporation | JXO |
| Apr 22, 2020 | K192517 | Psychemedics Microplate EIA for Cotinine in Hair Psychemedics Corporation | MKU |
| Apr 18, 2019 | K182103 | Psychemedics Microplate EIA for Fentanyl in Hair Psychemedics Corporation | DJG |
| Sep 15, 2017 | K163590 | Psychemedics Microplate EIA for Benzodiazepines in Hair Psychemedics Corporation | JXM |
| May 2, 2013 | K130811 | PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE Psychemedics Corp. | DKZ |
| Feb 8, 2013 | K123799 | PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR Psychemedics Corp. | DJG |
| May 1, 2012 | K111929 | PSYCHEMEDICS CANNABINOIDS EIA Psychemedics Corp. | LDJ |
| May 1, 2012 | K111928 | PSYCHEMEDICS PHENCYCLIDINE EIA Psychemedics Corp. | LCM |
| May 1, 2012 | K111927 | PSYCHEMEDICS METHAMPHETAMINE EIA Psychemedics Corp. | LAF |
| May 1, 2012 | K111926 | PSYCHEMEDICS OPIATES EIA Psychemedics Corp. | DJG |
| May 1, 2012 | K111925 | PSYCHEMEDICS COCAINE EIA Psychemedics Corp. | JXO |
| May 3, 2002 | K011426 | PSYCHEMEDICS RIA CANNABINOID ASSAY Psychemedics Corp. | LAT |
| Feb 11, 2002 | K011275 | PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY Psychemedics Corp. | LCL |
| Jan 24, 2002 | K011185 | PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY Psychemedics Corp. | DJC |
| Nov 6, 2001 | K010868 | PSYCHEMEDICS RIA COCAINE ASSAY Psychemedics Corp. | KLN |
| Dec 11, 2000 | K000851 | PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR Psychemedics Corp. | DJG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||