The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Verdict -ii Bar/bzo.
| Device ID | K010561 |
| 510k Number | K010561 |
| Device Name: | VERDICT -II BAR/BZO |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-26 |
| Decision Date | 2001-04-05 |