The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Profile-er.
| Device ID | K002331 |
| 510k Number | K002331 |
| Device Name: | PROFILE-ER |
| 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 |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-01 |
| Decision Date | 2001-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690286000537 | K002331 | 000 |
| 10690286000275 | K002331 | 000 |
| 10690286000268 | K002331 | 000 |
| 10690286000213 | K002331 | 000 |
| 10690286000206 | K002331 | 000 |
| 10690286000190 | K002331 | 000 |
| 10690286000183 | K002331 | 000 |
| 10690286000176 | K002331 | 000 |
| 10690286000701 | K002331 | 000 |
| 00690286000780 | K002331 | 000 |
| 10690286000282 | K002331 | 000 |
| 10690286000299 | K002331 | 000 |
| 00690286000520 | K002331 | 000 |
| 00690286000513 | K002331 | 000 |
| 00690286000476 | K002331 | 000 |
| 10690286000435 | K002331 | 000 |
| 10690286000404 | K002331 | 000 |
| 00690286000360 | K002331 | 000 |
| 00690286000353 | K002331 | 000 |
| 00690286000339 | K002331 | 000 |
| 00690286000315 | K002331 | 000 |
| 10690286000770 | K002331 | 000 |