510(k) Report

Devices descending from K043443

14 later devices reach One Step HCG Urine Pregnancy Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233624HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One…Hangzhou Aichek Medical Technology Co., Ltd.20240—
+1K230038MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)Guangzhou Decheng Biotechnology Co., Ltd.20230—
+1K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamSafecare Biotech (Hangzhou) Co., Ltd.20201—
+1K192843INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette…Innovita (Tangshan) Biological Technology Co., Ltd.20190—
+1K192123HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP…Qingdao Hightop Biotech Co., Ltd.20191—
+1K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteRunbio Biotech Co.,Ltd20180—
+1K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd.20182—
+1K150063One Step hCG Pregnancy TestCoretests, Inc.20151—
+1K081150Rapidan Optima Early Pregnancy Test and Toyo Pregnancy TestTurklab Medical Devices, Inc.20090—
+2K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene…Nanjing Synthgene Medical Technology Co., Ltd.20250—
+2K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette…Anhui Deepblue Medical Technology Co., Ltd.20240—
+2K230741Macro & Micro-Test HCG Pregnancy Test MidstreamJiangsu Macro & Micro-Test Med-Tech Co., Ltd.20230—
+2K222305MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd.20221—
+3K241978Shinetell Digital Pregnancy TestHangzhou AllTest Biotech Co., Ltd.20240—