K002331 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 January 17, 2001, 169 days after receiving the submission on August 1, 2000.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K002331 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2000 |
| Decision Date | January 17, 2001 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |