K230238 is an FDA 510(k) clearance for the BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Shenzhen Bioeasy Biotechnology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 31, 2023, 60 days after receiving the submission on January 30, 2023.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K230238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2023 |
| Decision Date | March 31, 2023 |
| Days to Decision | 60 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 |