K043507 is an FDA 510(k) clearance for the ACON OXY II ONE STEP OXYCODONE TEST STRIP. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on February 25, 2005, 67 days after receiving the submission on December 20, 2004.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K043507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2004 |
| Decision Date | February 25, 2005 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |