K020787 is an FDA 510(k) clearance for the VERDICT-II PROPOXYPHENE. This device is classified as a Enzyme Immunoassay, Propoxyphene (Class II - Special Controls, product code JXN).
Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on May 2, 2002, 52 days after receiving the submission on March 11, 2002.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3700.
| 510(k) Number | K020787 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2002 |
| Decision Date | May 02, 2002 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | JXN — Enzyme Immunoassay, Propoxyphene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3700 |