The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Verdict -ii Thc/coc/opi/amp/pcp/bar/bzo & Thc/coc/bar/bzo; Profile -ii 7 Thc/coc/opi/amp/pcp/bar/bzo.
| Device ID | K010564 |
| 510k Number | K010564 |
| Device Name: | VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-26 |
| Decision Date | 2001-04-05 |