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FDA 510(k) Applications Submitted by VivaChek Biotech (Hangzhou) Co., Ltd
FDA 510(k) Number
Submission Date
Device Name
Applicant
K231978
07/03/2023
BioSieveÖ Marijuana Test Panel 50; BioSieveÖ Marijuana Test Strip 50; BioSieveÖ Dx Marijuana Test Strip 20; BioSieveÖ Dx Marijuana Test Strip 50; BioSieveÖ Dx Marijuana Test Panel 20; BioSieveÖ Dx Marijuana Test Panel 50
VivaChek Biotech (Hangzhou) Co., Ltd
K222667
09/06/2022
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
Vivachek Biotech (Hangzhou) Co., Ltd
K192957
10/21/2019
VivaChek Blood Glucose and B-Ketone Monitoring System
Vivachek Biotech (Hangzhou) Co., Ltd
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