K220046 is an FDA 510(k) clearance for the Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Shenzhen Superbio Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 13, 2022, 342 days after receiving the submission on January 5, 2022.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K220046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2022 |
| Decision Date | December 13, 2022 |
| Days to Decision | 342 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 |