FDA 510(k) Applications Submitted by Max Zhang

FDA 510(k) Number Submission Date Device Name Applicant
K240124 01/16/2024 BioSieveÖ Fentanyl FIA Test Kit; BioSieveÖ ToxiSmart FIA Reader VivaChek Biotech (Hangzhou) Co., Ltd
K241869 06/27/2024 BioSieveÖ Fentanyl FIA Home Test Kit; BioSieveÖ Fentanyl FIA Pro Test Kit; BioSieveÖ Toxismart Reader VivaChek Biotech (Hangzhou) Co., Ltd


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