# Medtox Diagnostics, Inc.

- Location (FDA's records): Burlington, NC
- FDA decisions: 22 (1998–2026): 22 510(k) clearances
- Product codes: DJG (7), DIS (4), DKZ (3), DKE (2), DJC (2), LDJ (1), LCM (1), JXN (1), LFG (1)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 14 (5 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)
- Chemtron Biotech, Inc.: 1 (https://510kreport.com/company/chemtron-biotech)
- Microgenics Corp.: 1 (https://510kreport.com/company/microgenics)
- Biosite Incorporated: 1 (https://510kreport.com/company/biosite)

## Firms that cite its devices most
- Guangzhou Wondfo Biotech Co., Ltd.: 3 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Randox Laboratories, Ltd.: 2 (https://510kreport.com/company/randox-laboratories)
- Genprime, Inc.: 2 (https://510kreport.com/company/genprime)
- American Bio Medica Corp.: 1 (https://510kreport.com/company/american-bio-medica)
- Princeton BioMeditech Corp.: 1 (https://510kreport.com/company/princeton-biomeditech)

## Its most-cited devices
- K091454: Profile-V Medtoxscan Drugs of Abuse Test System (2009), cited by 3
- K050394: Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone, Opiates, Phencyclidine & Cannabinoids (2005), cited by 3
- K080635: Medtoxscan (2009), cited by 3
- K060351: Medtox Oxycodone (2006), cited by 2
- K010226: Verdict -II Methamphetamine (2001), cited by 1
- K002331: Profile-ER (2001), cited by 1

## Recent decisions
- K252684: Labcorp Fentanyl Urine Visual Test (Jan 29, 2026)
- K100951: Medtox Buprenorphine Test (Oct 18, 2010)
- K100023: Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test System (Apr 5, 2010)
- K091454: Profile-V Medtoxscan Drugs of Abuse Test System (Jul 24, 2009)
- K080635: Medtoxscan (Feb 13, 2009)
- K060351: Medtox Oxycodone (May 12, 2006)
- K050394: Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone, Opiates, Phencyclidine & Cannabinoids (Oct 25, 2005)
- K033334: Profile -ER (Nov 10, 2003)

Source page: https://510kreport.com/company/medtox-diagnostics