BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader— 510(k) K241869
Substantially EquivalentVivachek 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.. Device class: 2.
Clearance details
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
- Product code
- Code NGL
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- 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.
view all- K261280 — BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel
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- K233058 — VivaChek Link Plus Blood Glucose Monitoring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.