K233062
- 510(k) number
- K233062
- Device name
- BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd. CN
- Product code
- NFT — Test, Amphetamine, Over The Counter
- Decision date
- 2023-11-02
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233062.pdf
Official FDA record: K233062
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.