BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader— 510(k) K241869

Substantially Equivalent

Vivachek Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K241869 for BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader, Substantially Equivalent on 2024-10-04. Applicant: Vivachek Biotech (Hangzhou) Co., Ltd..

Clearance details

Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
Product code: Code NGL
Advisory panel: Clinical Toxicology
Date received: 2024-06-27
Decision date: 2024-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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