The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Profile-ii Model 600582.
| Device ID | K982211 |
| 510k Number | K982211 |
| Device Name: | PROFILE-II MODEL 600582 |
| Classification | Reagents, Test, Tetrahydrocannabinol |
| 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 | DKE |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LCM |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-23 |
| Decision Date | 1998-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690286000483 | K982211 | 000 |
| 10690286000152 | K982211 | 000 |
| 10690286000695 | K982211 | 000 |