K031032 is an FDA 510(k) clearance for the VERDICT II, PROFILE II. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on July 14, 2003, 104 days after receiving the submission on April 1, 2003.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K031032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2003 |
| Decision Date | July 14, 2003 |
| Days to Decision | 104 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |