K012595 is an FDA 510(k) clearance for the ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE. This device is classified as a Enzyme Immunoassay, Methadone (Class II - Special Controls, product code DJR).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on October 15, 2001, 66 days after receiving the submission on August 10, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3620.
| 510(k) Number | K012595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2001 |
| Decision Date | October 15, 2001 |
| Days to Decision | 66 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 |