FDA 510(k) Applications Submitted by Kaiyu Xiao

FDA 510(k) Number Submission Date Device Name Applicant
K241741 06/17/2024 SAFElifeÖ Fentanyl Urine Home Test (Cassette); SAFElifeÖ Fentanyl (FTY) Urine Test Cassette; SAFElifeÖ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElifeÖ T-Dip Fentanyl (FTY) Urine Test Panel Guangzhou Wondfo Biotech Co., Ltd.
K243256 10/15/2024 WELLlifeÖ COVID-19 / Influenza A&B Home Test; WELLlifeÖ COVID-19 / Influenza A&B AntigenTest Wondfo USA Co., Ltd.


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