The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Profile-v Medtoxscan Drugs Of Abuse Test System And 12 Drugs Test System.
| Device ID | K100023 |
| 510k Number | K100023 |
| Device Name: | PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Contact | Phillip Hartzog |
| Correspondent | Phillip Hartzog MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-05 |
| Decision Date | 2010-04-05 |
| Summary: | summary |