Drug Detection Devices, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Drug Detection Devices, Ltd.” (first 1999, latest 2000), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 70 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent Drug Detection Devices, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000452 | SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST | LAF | 2000-04-24 | 73 |
| K000522 | SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST | DIS | 2000-04-18 | 62 |
| K000402 | SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST | LCM | 2000-04-18 | 71 |
| K000400 | SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST | DKZ | 2000-04-18 | 71 |
| K000350 | SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST | DIO | 2000-04-11 | 68 |
| K000449 | SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST | JXM | 2000-04-07 | 56 |
| K000273 | SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST | DJG | 2000-04-07 | 70 |
| K992949 | SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST | LDJ | 1999-12-27 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Drug Detection Devices, Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Drug Screening Systems, Inc. (8 510(k)s)
- Drug Free Enterprises (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Drug Detection Devices, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Drug Detection Devices, Ltd.” (first 1999, latest 2000), across 8 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 Drug Detection Devices, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Drug Detection Devices, Ltd. is 70 days.
Which FDA product codes appear under Drug Detection Devices, Ltd.?
The most frequent FDA product codes under this applicant name are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); DIS (Enzyme Immunoassay, Barbiturate, 1); DJG (Enzyme Immunoassay, Opiates, 1).
Next steps
- See all 8 Drug Detection Devices, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DIO, Drug Detection Devices, Ltd.'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.