BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader— 510(k) K240124
Substantially EquivalentVivachek 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.. Device class: 2.
Clearance details
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
- Product code
- Code DJG
- 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
Recent devices under product code DJG
view allMore clearances from Vivachek Biotech (Hangzhou) Co., Ltd.
view all- K261280 — BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel
- K252554 — Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
- K241869 — BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader
- K222126 — VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System
- K233058 — VivaChek Link Plus Blood Glucose Monitoring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.