Documento fuente o registro público
FDA 510(k) K233062 — BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
FDA 510(k) index record K233062. Device: BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2023-11-02.
Fuente
"device_name": "BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-28
professional use
FDA 510(k) public index record K233062.
Device name: BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd..
Decision date: 2023-11-02. Decision wording: Substantially Equivalent.
Product code: NFT. Regulation: 21 CFR 862.3100. Medical specialty: Clinical Toxicology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.