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Vivachek Biotech (Hangzhou) Co., Ltd.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories6
Latest FDA decision2026-05-22
TypeNumberDevice NameCodeDateActions
510(k) K261280 BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelNFT2026-05-22 View
510(k) K252554 Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupNFT2025-09-12 View
510(k) K241869 BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart ReaderNGL2024-10-04 View
510(k) K222126 VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring SystemNBW2024-08-16 View
510(k) K240124 BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderDJG2024-06-14 View
510(k) K233058 VivaChek Link Plus Blood Glucose Monitoring SystemNBW2023-12-22 View
510(k) K233062 BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel RxNFT2023-11-02 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 50NFW2023-08-31 View
510(k) K222667 Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup RxNFT2022-11-10 View
510(k) K192957 VivaChek Blood Glucose and B-Ketone Monitoring SystemJIN2020-06-05 View
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