K200197 is an FDA 510(k) clearance for the ARK Fentanyl II 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 February 26, 2020, 30 days after receiving the submission on January 27, 2020.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K200197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2020 |
| Decision Date | February 26, 2020 |
| Days to Decision | 30 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 |