510(k) Report

Devices descending from K182701

13 later devices reach Wondfo T-Cup Multi-Drug Urine Test Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.20250—
+1K242077PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test CupAicheck Biotech, Inc.20240—
+1K222667Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup RxVivachek Biotech (Hangzhou) Co., Ltd.20221—
+1K220685HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup RxQingdao Hightop Biotech Co., Ltd.20220—
+1K210327First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign…W.H.P.M., Inc.20210—
+1K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxGuangzhou Wondfo Biotech Co., Ltd.20204—
+1K191841Accurate Multi Panel Drug Urine Test CupHealstone Biotech, Inc.20191—
+2K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.20260—
+2K252554Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupVivachek Biotech (Hangzhou) Co., Ltd.20250—
+2K242498Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTCAicheck Biotech, Inc.20240—
+2K233062BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel RxVivachek Biotech (Hangzhou) Co., Ltd.20231—
+2K221871Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of…Healstone Biotech, Inc.20220—
+3K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.20260—