The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Verdict Ii, Profile Ii.
| Device ID | K031032 |
| 510k Number | K031032 |
| Device Name: | VERDICT II, PROFILE II |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Contact | Alan Morris |
| Correspondent | Alan Morris MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Product Code | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-01 |
| Decision Date | 2003-07-14 |