Vivachek Biotech (Hangzhou) Co., Ltd.
FDA 510(k) & PMA Approved Devices — 9 products
Total Devices9
Categories6
Latest Approval2025-09-12
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | NFT | 2025-09-12 | View |
| 510(k) | K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader | NGL | 2024-10-04 | View |
| 510(k) | K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System | NBW | 2024-08-16 | View |
| 510(k) | K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | DJG | 2024-06-14 | View |
| 510(k) | K233058 | VivaChek Link Plus Blood Glucose Monitoring System | NBW | 2023-12-22 | View |
| 510(k) | K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | NFT | 2023-11-02 | View |
| 510(k) | K231978 | BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50 | NFW | 2023-08-31 | View |
| 510(k) | K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | NFT | 2022-11-10 | View |
| 510(k) | K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | JIN | 2020-06-05 | View |
No matching devices.