Medical Device Manufacturer · US , Burlington , NC

Medtox Diagnostics, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1998

Recent clearances: Labcorp Fentanyl Urine Visual Test

22
Total
22
Cleared
0
Denied

Medtox Diagnostics, Inc. has 22 FDA 510(k) cleared toxicology devices. Based in Burlington, US.

Latest FDA clearance: Jan 2026. Active since 1998.

Browse the complete list of FDA 510(k) cleared toxicology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Medtox Diagnostics, Inc.

22 devices
1-22 of 22
Cleared Jan 29, 2026
Labcorp Fentanyl Urine Visual Test
K252684 · DJG
Toxicology · 157d
Cleared Oct 18, 2010
MEDTOX BUPRENORPHINE TEST
K100951 · DJG
Chemistry · 195d
Cleared Apr 05, 2010
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
K100023 · DJG
Toxicology · 90d
Cleared Jul 24, 2009
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
K091454 · DJG
Toxicology · 67d
Cleared Feb 13, 2009
MEDTOXSCAN
K080635 · DKZ
Chemistry · 344d
Cleared May 12, 2006
MEDTOX OXYCODONE
K060351 · DJG
Toxicology · 88d
Cleared Oct 25, 2005
SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA,...
K050394 · DKZ
Chemistry · 251d
Cleared Nov 10, 2003
PROFILE -ER
K033334 · DIS
Toxicology · 25d
Cleared Jul 14, 2003
VERDICT II, PROFILE II
K031032 · DJG
Toxicology · 104d
Cleared Jul 30, 2002
VERDICT-II
K022141 · DJC
Toxicology · 28d
Cleared May 02, 2002
VERDICT-II PROPOXYPHENE
K020787 · JXN
Toxicology · 52d
Cleared Jun 08, 2001
VERDICT -II TCA, VERDICT-II MTD
K011545 · LFG
Toxicology · 21d
Cleared Jun 01, 2001
VERDICT -II METHAMPHETAMINE
K010226 · DJC
Toxicology · 128d
Cleared Apr 13, 2001
VERDICT -II BAR
K010959 · DIS
Toxicology · 14d
Cleared Apr 05, 2001
VERDICT -II BAR/BZO
K010561 · DIS
Toxicology · 38d
Cleared Apr 05, 2001
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO
K010564 · DKZ
Toxicology · 38d
Cleared Feb 14, 2001
PROFILE II ER
K010138 · LDJ
Toxicology · 28d
Cleared Jan 17, 2001
PROFILE-ER
K002331 · DIS
Toxicology · 169d
Cleared Dec 22, 2000
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II...
K003687 · DKE
Toxicology · 22d
Cleared Sep 28, 2000
MODIFICATION TO PROFILE -II
K002776 · LCM
Toxicology · 22d
Cleared Dec 16, 1999
VERDICT -II OPIATES 2000
K992111 · DJG
Toxicology · 177d
Cleared Jul 29, 1998
PROFILE-II MODEL 600582
K982211 · DKE
Toxicology · 36d
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