K010561 is an FDA 510(k) clearance for the VERDICT -II BAR/BZO. This device is classified as a Enzyme Immunoassay, Barbiturate (Class II - Special Controls, product code DIS).
Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on April 5, 2001, 38 days after receiving the submission on February 26, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K010561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2001 |
| Decision Date | April 05, 2001 |
| Days to Decision | 38 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |