U.S. Drug Testing, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “U.S. Drug Testing, Inc.” (first 1993, latest 1994), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 59 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 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| KZR | Chromatography (Liquid, Gel), Clinical Use | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent U.S. Drug Testing, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940912 | USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 | LDJ | 1994-06-02 | 97 |
| K935629 | USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 | LCM | 1994-04-12 | 140 |
| K934693 | AMPHETAMINE TEST SYSTEM | DKZ | 1993-11-22 | 53 |
| K932318 | USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 | DJG | 1993-06-15 | 35 |
| K931227 | USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 | KZR | 1993-05-06 | 57 |
| K930985 | USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 | DIO | 1993-04-27 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named U.S. Drug Testing, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under U.S. Drug Testing, Inc.?
FDA lists 6 510(k) clearances under the applicant name “U.S. Drug Testing, Inc.” (first 1993, latest 1994), across 6 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 U.S. Drug Testing, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name U.S. Drug Testing, Inc. is 59 days.
Which FDA product codes appear under U.S. Drug Testing, Inc.?
The most frequent FDA product codes under this applicant name are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); DJG (Enzyme Immunoassay, Opiates, 1); DKZ (Enzyme Immunoassay, Amphetamine, 1).
Next steps
- See all 6 U.S. Drug Testing, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIO, U.S. Drug Testing, 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, 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.