The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Verdict -ii Opiates 2000.
| Device ID | K992111 |
| 510k Number | K992111 |
| Device Name: | VERDICT -II OPIATES 2000 |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | 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 | 1999-06-22 |
| Decision Date | 1999-12-16 |