Company ยท US
Medtox Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2026. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (1 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 7 |
| DIS | Enzyme Immunoassay, Barbiturate | 4 |
| DKZ | Enzyme Immunoassay, Amphetamine | 4 |
| DJC | Thin Layer Chromatography, Methamphetamine | 2 |
| DKE | Reagents, Test, Tetrahydrocannabinol | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| JXN | Enzyme Immunoassay, Propoxyphene | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 29, 2026 | K252684 | Labcorp Fentanyl Urine Visual Test Medtox Diagnostics, Inc. | DJG |
| Oct 18, 2010 | K100951 | MEDTOX BUPRENORPHINE TEST Medtox Diagnostics, Inc. | DJG |
| Apr 5, 2010 | K100023 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM Medtox Diagnostics, Inc. | DJG |
| Jul 24, 2009 | K091454 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM Medtox Diagnostics, Inc. | DJG |
| Feb 13, 2009 | K080635 | MEDTOXSCAN Medtox Diagnostics, Inc. | DKZ |
| May 12, 2006 | K060351 | MEDTOX OXYCODONE Medtox Diagnostics, Inc. | DJG |
| Oct 25, 2005 | K050394 | SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS Medtox Diagnostics, Inc. | DKZ |
| Nov 10, 2003 | K033334 | PROFILE -ER Medtox Diagnostics, Inc. | DIS |
| Jul 14, 2003 | K031032 | VERDICT II, PROFILE II Medtox Diagnostics, Inc. | DJG |
| Jul 30, 2002 | K022141 | VERDICT-II Medtox Diagnostics, Inc. | DJC |
| May 2, 2002 | K020787 | VERDICT-II PROPOXYPHENE Medtox Diagnostics, Inc. | JXN |
| Jun 8, 2001 | K011545 | VERDICT -II TCA, VERDICT-II MTD Medtox Diagnostics, Inc. | LFG |
| Jun 1, 2001 | K010226 | VERDICT -II METHAMPHETAMINE Medtox Diagnostics, Inc. | DJC |
| Apr 13, 2001 | K010959 | VERDICT -II BAR; VERDICT -II BZO Medtox Diagnostics, Inc. | DIS |
| Apr 5, 2001 | K010564 | VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO Medtox Diagnostics, Inc. | DKZ |
| Apr 5, 2001 | K010561 | VERDICT -II BAR/BZO Medtox Diagnostics, Inc. | DIS |
| Feb 14, 2001 | K010138 | PROFILE II ER Medtox Diagnostics, Inc. | LDJ |
| Jan 17, 2001 | K002331 | PROFILE-ER Medtox Diagnostics, Inc. | DIS |
| Dec 22, 2000 | K003687 | VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC Medtox Diagnostics, Inc. | DKE |
| Sep 28, 2000 | K002776 | MODIFICATION TO PROFILE -II Medtox Diagnostics, Inc. | LCM |
| Dec 16, 1999 | K992111 | VERDICT -II OPIATES 2000 Medtox Diagnostics, Inc. | DJG |
| Jul 29, 1998 | K982211 | PROFILE-II MODEL 600582 Medtox Diagnostics, Inc. | DKE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2013 | Medtox Diagnostics Inc PROFILE-V MEDTOXScan Drugs of Abuse Test System.
For the rapid, qualitative detection of drugs of abuse in human urine, Terminated |
DIO | K080635 |
| Sep 26, 2008 | Medtox Diagnostics Inc MEDTOXscan Reader Terminated |
DKZ | None listed |