K232659
- 510(k) number
- K232659
- Device name
- Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
- Applicant
- Guangzhou Decheng Biotechnology Co., Ltd. CN
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2023-12-13
- Date received
- 2023-08-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
510(k) Summary (official FDA PDF): K232659.pdf
Official FDA record: K232659
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.