K261280
- 510(k) number
- K261280
- Device name
- BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd. CN
- Product code
- NFT — Test, Amphetamine, Over The Counter
- Decision date
- 2026-05-22
- Date received
- 2026-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K261280.pdf
Official FDA record: K261280
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.