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Guangzhou Wondfo Biotech Co., Ltd.

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

Total Devices10
Categories7
Latest FDA decision2026-04-28
TypeNumberDevice NameCodeDateActions
510(k) K260065 SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxNFT2026-04-28 View
510(k) K252550 SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxNFT2025-11-18 View
510(k) K251289 WELLlife COVID-19 Antigen Test RxQVF2025-10-22 View
510(k) K241317 Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)QYT2024-09-30 View
510(k) K241741 SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test PanelNGL2024-07-16 View
510(k) K202567 Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxNFT2020-09-25 View
510(k) K182701 Wondfo T-Cup Multi-Drug Urine Test CupNFT2018-12-03 View
510(k) K173229 Preview Digital Pregnancy TestLCX2018-03-12 View
510(k) K162333 Wondfo One Step Fecal Occult Blood (FOB) TestKHE2017-05-14 View
510(k) K161214 Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)DIO2016-06-27 View
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