BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader— 510(k) K240124

Substantially Equivalent

Vivachek Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K240124 for BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader, Substantially Equivalent on 2024-06-14. Applicant: Vivachek Biotech (Hangzhou) Co., Ltd..

Clearance details

Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2024-01-16
Decision date: 2024-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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