Medtox Diagnostics Inc
FDA Regulatory Profile
Medtox Diagnostics Inc appears in FDA public data with 1 recall, 22 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1329-2013, Class II) was initiated on April 5, 2013. Its most recent 510(k) clearance was granted on January 29, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 22
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
| Z-1329-2013 | Class II | PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of | April 5, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
| K252684 | Labcorp Fentanyl Urine Visual Test | January 29, 2026 |
| K100951 | MEDTOX BUPRENORPHINE TEST | October 18, 2010 |
| K100023 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM | April 5, 2010 |
| K091454 | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM | July 24, 2009 |
| K080635 | MEDTOXSCAN | February 13, 2009 |
| K060351 | MEDTOX OXYCODONE | May 12, 2006 |
| K050394 | SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCL | October 25, 2005 |
| K033334 | PROFILE -ER | November 10, 2003 |
| K031032 | VERDICT II, PROFILE II | July 14, 2003 |
| K022141 | VERDICT-II | July 30, 2002 |
| K020787 | VERDICT-II PROPOXYPHENE | May 2, 2002 |
| K011545 | VERDICT -II TCA, VERDICT-II MTD | June 8, 2001 |
| K010226 | VERDICT -II METHAMPHETAMINE | June 1, 2001 |
| K010959 | VERDICT -II BAR; VERDICT -II BZO | April 13, 2001 |
| K010561 | VERDICT -II BAR/BZO | April 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 | April 5, 2001 |
| K010138 | PROFILE II ER | February 14, 2001 |
| K002331 | PROFILE-ER | January 17, 2001 |
| K003687 | VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERD | December 22, 2000 |
| K002776 | MODIFICATION TO PROFILE -II | September 28, 2000 |