K990409 is an FDA 510(k) clearance for the ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K). This device is classified as a Gas Chromatography, Morphine (Class II - Special Controls, product code DMY).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 15, 1999, 65 days after receiving the submission on February 9, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3640.
| 510(k) Number | K990409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1999 |
| Decision Date | April 15, 1999 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DMY — Gas Chromatography, Morphine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3640 |