Medical Device Manufacturer · US , Burlington , NC

Medtox Diagnostics, Inc.

22 submissions · 22 cleared · Since 1998
22
Total
22
Cleared
0
Denied

Medtox Diagnostics, Inc. — FDA 510(k) Submissions

Medtox Diagnostics, Inc. has submitted 22 FDA 510(k) premarket notifications since 1998, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Barbiturate, Enzyme Immunoassay, Amphetamine, Reagents, Test, Tetrahydrocannabinol, Thin Layer Chromatography, Methamphetamine . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
Labcorp Fentanyl Urine Visual Test
K252684 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jan 2026 157d
MEDTOX BUPRENORPHINE TEST
K100951 · DJG Enzyme Immunoassay, Opiates · Chemistry
Oct 2010 195d
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
K100023 · DJG Enzyme Immunoassay, Opiates · Toxicology
Apr 2010 90d
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
K091454 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jul 2009 67d
MEDTOXSCAN
K080635 · DKZ Enzyme Immunoassay,... · Chemistry
Feb 2009 344d
MEDTOX OXYCODONE
K060351 · DJG Enzyme Immunoassay, Opiates · Toxicology
May 2006 88d
SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS
K050394 · DKZ Enzyme Immunoassay,... · Chemistry
Oct 2005 251d
PROFILE -ER
K033334 · DIS Enzyme Immunoassay,... · Toxicology
Nov 2003 25d
VERDICT II, PROFILE II
K031032 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jul 2003 104d
VERDICT-II
K022141 · DJC Thin Layer... · Toxicology
Jul 2002 28d
VERDICT-II PROPOXYPHENE
K020787 · JXN Enzyme Immunoassay,... · Toxicology
May 2002 52d
VERDICT -II TCA, VERDICT-II MTD
K011545 · LFG Radioimmunoassay,... · Toxicology
Jun 2001 21d
VERDICT -II METHAMPHETAMINE
K010226 · DJC Thin Layer... · Toxicology
Jun 2001 128d
VERDICT -II BAR; VERDICT -II BZO
K010959 · DIS Enzyme Immunoassay,... · Toxicology
Apr 2001 14d
VERDICT -II BAR/BZO
K010561 · DIS Enzyme Immunoassay,... · Toxicology
Apr 2001 38d
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO
K010564 · DKZ Enzyme Immunoassay,... · Toxicology
Apr 2001 38d
PROFILE II ER
K010138 · LDJ Enzyme Immunoassay,... · Toxicology
Feb 2001 28d
PROFILE-ER
K002331 · DIS Enzyme Immunoassay,... · Toxicology
Jan 2001 169d
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
K003687 · DKE Reagents, Test,... · Toxicology
Dec 2000 22d
MODIFICATION TO PROFILE -II
K002776 · LCM Enzyme Immunoassay,... · Toxicology
Sep 2000 22d
VERDICT -II OPIATES 2000
K992111 · DJG Enzyme Immunoassay, Opiates · Toxicology
Dec 1999 177d
PROFILE-II MODEL 600582
K982211 · DKE Reagents, Test,... · Toxicology
Jul 1998 36d
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