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
- Product 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- K260687 — VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System +1 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.