Psychemedics Corp.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Psychemedics Corp.” (first 2000, latest 2022), across 12 product codes in 1 review panel. Median 510(k) review time under this name: 291 days. Since 2017 the median was 269 days, against 150 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 300 |
| 2013 | 2 | 49 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 269 |
| 2018 | 0 | — |
| 2019 | 1 | 258 |
| 2020 | 1 | 222 |
| 2021 | 3 | 414 |
| 2022 | 1 | 214 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Psychemedics Corp. took a median 269 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 5 | 5 |
| JXO | Enzyme Immunoassay, Cocaine | 2 | 2 |
| LAF | Gas Chromatography, Methamphetamine | 2 | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | 2 | 2 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 | 1 |
| KLN | Radioimmunoassay, Cocaine Metabolite | 1 | 1 |
| LAT | Radioimmunoassay, Cannabinoid(S) | 1 | 1 |
| LCL | Radioimmunoassay, Phencyclidine | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Toxicology (19)
Most recent Psychemedics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | LCM | 2022-04-18 | 214 |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | LAF | 2021-12-15 | 322 |
| K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair | DJG | 2021-07-27 | 434 |
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair | JXO | 2021-06-25 | 414 |
| K192517 | Psychemedics Microplate EIA for Cotinine in Hair | MKU | 2020-04-22 | 222 |
| K182103 | Psychemedics Microplate EIA for Fentanyl in Hair | DJG | 2019-04-18 | 258 |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in Hair | JXM | 2017-09-15 | 269 |
| K130811 | PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE | DKZ | 2013-05-02 | 38 |
| K123799 | PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR | DJG | 2013-02-08 | 60 |
| K111929 | PSYCHEMEDICS CANNABINOIDS EIA | LDJ | 2012-05-01 | 300 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Psychemedics Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Psychemedics Corp.?
FDA lists 19 510(k) clearances under the applicant name “Psychemedics Corp.” (first 2000, latest 2022), across 12 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Psychemedics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Psychemedics Corp. is 291 days. Since 2017: 269 days, versus 150 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Psychemedics Corp.?
The most frequent FDA product codes under this applicant name are DJG (Enzyme Immunoassay, Opiates, 5); JXO (Enzyme Immunoassay, Cocaine, 2); LAF (Gas Chromatography, Methamphetamine, 2).
Next steps
- See all 19 Psychemedics Corp. clearances with predicates and recalls
- Run predicate analysis for product code DJG, Psychemedics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.