The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Profile -er.
| Device ID | K033334 |
| 510k Number | K033334 |
| Device Name: | PROFILE -ER |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Contact | Alan Morris |
| Correspondent | Alan Morris MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Product Code | DIS |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-16 |
| Decision Date | 2003-11-10 |