K252554
- 510(k) number
- K252554
- Device name
- Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd. CN
- Product code
- NFT — Test, Amphetamine, Over The Counter
- Decision date
- 2025-09-12
- Date received
- 2025-08-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252554.pdf
Official FDA record: K252554
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.