The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Verdict -ii Methamphetamine.
| Device ID | K010226 |
| 510k Number | K010226 |
| Device Name: | VERDICT -II METHAMPHETAMINE |
| Classification | Thin Layer Chromatography, Methamphetamine |
| Applicant | MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Contact | Micheal Turanchik |
| Correspondent | Micheal Turanchik MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Product Code | DJC |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-24 |
| Decision Date | 2001-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690286000506 | K010226 | 000 |
| 10690286000220 | K010226 | 000 |
| 10690286000237 | K010226 | 000 |
| 10690286000251 | K010226 | 000 |
| 00690286000308 | K010226 | 000 |
| 10690286000381 | K010226 | 000 |
| 00690286000391 | K010226 | 000 |
| 10690286000411 | K010226 | 000 |
| 10690286000428 | K010226 | 000 |
| 10690286000442 | K010226 | 000 |
| 00690286000469 | K010226 | 000 |
| 00690286000490 | K010226 | 000 |
| 10690286000169 | K010226 | 000 |