K982211 is an FDA 510(k) clearance for the PROFILE-II MODEL 600582. This device is classified as a Reagents, Test, Tetrahydrocannabinol (Class II - Special Controls, product code DKE).
Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on July 29, 1998, 36 days after receiving the submission on June 23, 1998.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K982211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1998 |
| Decision Date | July 29, 1998 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DKE — Reagents, Test, Tetrahydrocannabinol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |