The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Profile Ii Er.
| Device ID | K010138 |
| 510k Number | K010138 |
| Device Name: | PROFILE II ER |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-17 |
| Decision Date | 2001-02-14 |