BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel— 510(k) K261280

Substantially Equivalent

Vivachek 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..

Clearance details

Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
Product code: Code NFT
Advisory panel: Clinical Toxicology
Date received: 2026-04-17
Decision date: 2026-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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