K232228
- 510(k) number
- K232228
- Device name
- Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card
- Applicant
- Shanghai Accurature Diagnostics Co., Ltd. CN
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2024-02-23
- Date received
- 2023-07-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232228.pdf
Official FDA record: K232228
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.