BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel— 510(k) K261280
Substantially EquivalentVivachek Biotech (Hangzhou) Co., Ltd.
FDA 510(k) clearance K261280 for BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel, Substantially Equivalent on 2026-05-22. Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
- Product code
- Code NFT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
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More clearances from Vivachek Biotech (Hangzhou) Co., Ltd.
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Data sourced from openFDA. This site is unofficial and independent of the FDA.