Psychemedics Corp.
Cambridge, MA, US
Psychemedics Corp. appears in FDA device records in Cambridge, MA. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Psychemedics Corp. between 2000 and 2022. The busiest year on record is 2012, with 5. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 3 |
| 2012 | 5 |
| 2013 | 2 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | LCM | Substantially Equivalent | |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | LAF | Substantially Equivalent | |
| K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair | DJG | Substantially Equivalent | |
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair | JXO | Substantially Equivalent | |
| K192517 | Psychemedics Microplate EIA for Cotinine in Hair | MKU | Substantially Equivalent | |
| K182103 | Psychemedics Microplate EIA for Fentanyl in Hair | DJG | Substantially Equivalent | |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in Hair | JXM | Substantially Equivalent | |
| K130811 | PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE | DKZ | Substantially Equivalent | |
| K123799 | PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR | DJG | Substantially Equivalent | |
| K111929 | PSYCHEMEDICS CANNABINOIDS EIA | LDJ | Substantially Equivalent | |
| K111928 | PSYCHEMEDICS PHENCYCLIDINE EIA | LCM | Substantially Equivalent | |
| K111927 | PSYCHEMEDICS METHAMPHETAMINE EIA | LAF | Substantially Equivalent | |
| K111926 | PSYCHEMEDICS OPIATES EIA | DJG | Substantially Equivalent | |
| K111925 | PSYCHEMEDICS COCAINE EIA | JXO | Substantially Equivalent | |
| K011426 | PSYCHEMEDICS RIA CANNABINOID ASSAY | LAT | Substantially Equivalent | |
| K011275 | PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY | LCL | Substantially Equivalent | |
| K011185 | PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY | DJC | Substantially Equivalent | |
| K010868 | PSYCHEMEDICS RIA COCAINE ASSAY | KLN | Substantially Equivalent | |
| K000851 | PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR | DJG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DKZEnzyme Immunoassay, Amphetamine
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- JXOEnzyme Immunoassay, Cocaine
- MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- LAFGas Chromatography, Methamphetamine
- LATRadioimmunoassay, Cannabinoid(S)
- KLNRadioimmunoassay, Cocaine Metabolite
- LCLRadioimmunoassay, Phencyclidine
- DJCThin Layer Chromatography, Methamphetamine
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain