Vivachek Biotech (Hangzhou) Co., Ltd.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | September 12, 2025 |
| K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reade | October 4, 2024 |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, | August 16, 2024 |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | June 14, 2024 |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | December 22, 2023 |
| K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | November 2, 2023 |
| K231978 | BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test St | August 31, 2023 |
| K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | November 10, 2022 |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | June 5, 2020 |