K010226 is an FDA 510(k) clearance for the VERDICT -II METHAMPHETAMINE. This device is classified as a Thin Layer Chromatography, Methamphetamine (Class II - Special Controls, product code DJC).
Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on June 1, 2001, 128 days after receiving the submission on January 24, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K010226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2001 |
| Decision Date | June 01, 2001 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DJC — Thin Layer Chromatography, Methamphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3610 |