510(k) Report

Devices descending from K150022

6 later devices reach Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…Guangzhou Decheng Biotechnology Co., Ltd.20250—
+1K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.20250—
+1K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…Assure Tech., LLC20250—
+1K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…Guangzhou Decheng Biotechnology Co., Ltd.20240—
+1K234152ACESO Early Pregnancy TestAceso Laboratories, Inc.20240—
+1K232864EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream IINantong Egens Biotechnology Co., Ltd.20240—