Medtox Diagnostics, Inc.: FDA clearances and approvals
Medtox Diagnostics, Inc. has 22 FDA 510(k) clearances (first 1998, latest 2026), across 9 product codes in 1 review panel. Median 510(k) review time: 60 days. openFDA lists 2 product recalls by a recalling firm named Medtox Diagnostics, Inc.
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 | 1 | 157 |
Review time against the same product codes
Since 2017, Medtox Diagnostics, Inc.'s cleared 510(k)s took a median 157 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 7 | 7 |
| DIS | Enzyme Immunoassay, Barbiturate | 4 | 4 |
| DKZ | Enzyme Immunoassay, Amphetamine | 3 | 3 |
| DJC | Thin Layer Chromatography, Methamphetamine | 2 | 2 |
| DKE | Reagents, Test, Tetrahydrocannabinol | 2 | 2 |
| JXN | Enzyme Immunoassay, Propoxyphene | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 1 | 1 |
Review panels
- Clinical Toxicology (22)
Most recent Medtox Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual Test | DJG | 2026-01-29 | 157 |
| K100951 | MEDTOX BUPRENORPHINE TEST | DJG | 2010-10-18 | 195 |
| K100023 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM | DJG | 2010-04-05 | 90 |
| K091454 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM | DJG | 2009-07-24 | 67 |
| K080635 | MEDTOXSCAN | DKZ | 2009-02-13 | 344 |
| K060351 | MEDTOX OXYCODONE | DJG | 2006-05-12 | 88 |
| K050394 | SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS | DKZ | 2005-10-25 | 251 |
| K033334 | PROFILE -ER | DIS | 2003-11-10 | 25 |
| K031032 | VERDICT II, PROFILE II | DJG | 2003-07-14 | 104 |
| K022141 | VERDICT-II | DJC | 2002-07-30 | 28 |
12 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2013-04-05.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medtox Diagnostics, Inc. have?
Medtox Diagnostics, Inc. has 22 FDA 510(k) clearances (first 1998, latest 2026), across 9 product codes in 1 review panel.
How long does FDA take to clear Medtox Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medtox Diagnostics, Inc.'s cleared 510(k)s is 60 days.
What devices does Medtox Diagnostics, Inc. make?
Its most frequent FDA product codes are DJG (Enzyme Immunoassay, Opiates, 7); DIS (Enzyme Immunoassay, Barbiturate, 4); DKZ (Enzyme Immunoassay, Amphetamine, 3).
Has Medtox Diagnostics, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Medtox Diagnostics, Inc; the most recent began 2013-04-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 22 Medtox Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DJG, Medtox Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.