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Guangzhou Wondfo Biotech Co., Ltd.

FDA 510(k) & PMA Approved Devices — 31 products

Total Devices31
Categories0
Latest FDA decision
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
510(k) K132630 WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)DJC2013-09-27 View
510(k) K131754 WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)DIO2013-07-31 View
510(k) K131232 WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)DJR2013-05-31 View
510(k) K130665 WONDOFO MULTI-DRUG URINE TEST CUP / PANELDJG2013-04-09 View
510(k) K130055 ACON BUP ONE STEP BUPRENORPHINE TEST STRIPDJG2013-02-14 View
510(k) K122961 WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)DKZ2012-12-21 View
510(k) K122904 WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;DKZ2012-11-15 View
510(k) K121987 WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TESTDKZ2012-08-01 View
510(k) K121557 WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TESTLDJ2012-07-25 View
510(k) K121166 WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANELDIO2012-05-08 View
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