K081378 is an FDA 510(k) clearance for the DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS. This device is classified as a Enzyme Immunoassay, Methadone (Class II - Special Controls, product code DJR).
Submitted by Thermo Fisher Scientific (Fremont Blvd., US). The FDA issued a Cleared decision on January 14, 2009, 243 days after receiving the submission on May 16, 2008.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3620.
| 510(k) Number | K081378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2008 |
| Decision Date | January 14, 2009 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJR — Enzyme Immunoassay, Methadone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3620 |