Drug Screening Systems, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Drug Screening Systems, Inc.” (first 1991, latest 1995), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 86 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 |
| DIT | Thin Layer Chromatography, Amphetamine | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent Drug Screening Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945829 | MICROLINE SCREEN FOR BENZODIAZEPINE | JXM | 1995-01-25 | 57 |
| K935052 | MICROLINE SCREEN FOR AMPHETAMINE | DKZ | 1994-09-16 | 331 |
| K933480 | MICROLINE SCREEN FOR BARBITURATES | DIS | 1993-10-29 | 106 |
| K921651 | MICROLINE SCREEN FOR PHENCYCLIDINE | LCM | 1992-07-08 | 93 |
| K914915 | MICROLINE SCREEN FOR CANNABINOID | LDJ | 1992-01-22 | 79 |
| K911652 | MIRCOLINE SCREEN FOR COCAINE | DIO | 1991-05-15 | 33 |
| K910525 | MICROLINE SCREEN FOR METHAMPHETAMINE | DIT | 1991-04-05 | 57 |
| K905491 | MICROLINE SCREEN FOR OPIATES | DJG | 1991-03-13 | 96 |
Recalls
openFDA lists no recalls under a recalling firm named Drug Screening Systems, Inc..
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 Detection Devices, Ltd. (8 510(k)s)
- Drug Free Enterprises (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Drug Screening Systems, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Drug Screening Systems, Inc.” (first 1991, latest 1995), 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 Screening Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Drug Screening Systems, Inc. is 86 days.
Which FDA product codes appear under Drug Screening Systems, Inc.?
The most frequent FDA product codes under this applicant name are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); DIS (Enzyme Immunoassay, Barbiturate, 1); DIT (Thin Layer Chromatography, Amphetamine, 1).
Next steps
- See all 8 Drug Screening Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIO, Drug Screening Systems, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.