The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Verdict-ii Propoxyphene.
| Device ID | K020787 |
| 510k Number | K020787 |
| Device Name: | VERDICT-II PROPOXYPHENE |
| Classification | Enzyme Immunoassay, Propoxyphene |
| Applicant | MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Contact | Michael Turanchik |
| Correspondent | Michael Turanchik MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Product Code | JXN |
| CFR Regulation Number | 862.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-11 |
| Decision Date | 2002-05-02 |