K010138 is an FDA 510(k) clearance for the PROFILE II ER. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on February 14, 2001, 28 days after receiving the submission on January 17, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K010138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2001 |
| Decision Date | February 14, 2001 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |