K240124

Substantially Equivalent

BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader

Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
Product 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.