K033334 is an FDA 510(k) clearance for the PROFILE -ER. 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 November 10, 2003, 25 days after receiving the submission on October 16, 2003.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K033334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2003 |
| Decision Date | November 10, 2003 |
| Days to Decision | 25 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 |