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Vivachek Biotech (Hangzhou) Co., Ltd. FDA Approvals

0 new drug approvals and 9 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel510(k)May 22, 2026Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	May 22, 2026
Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup510(k)Sep 12, 2025Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Sep 12, 2025
BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader510(k)Oct 4, 2024Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Oct 4, 2024
VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System510(k)Aug 16, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 16, 2024
BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader510(k)Jun 14, 2024Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Jun 14, 2024
VivaChek Link Plus Blood Glucose Monitoring System510(k)Dec 22, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Dec 22, 2023
BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx510(k)Nov 2, 2023Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Nov 2, 2023
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 50510(k)Aug 31, 2023Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Aug 31, 2023
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx510(k)Nov 10, 2022Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Nov 10, 2022

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