K231752 is an FDA 510(k) clearance for the ARK Hydrocodone Assay. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on November 9, 2023, 147 days after receiving the submission on June 15, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K231752 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2023 |
| Decision Date | November 09, 2023 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DJG - Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |