510(k) Report

Devices descending from K083716

17 later devices reach First Response Early Result Pregnancy Test (Otc) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123567First Response Gold Digital Pregnancy TestChurch & Dwight Co., Inc.20132—
+1K123436First Response Early Result Pregnancy TestChurch & Dwight Co., Inc.2013132
+2K213379Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH20221—
+2K212418hCG One Step Pregnancy TestHealstone Biotech, Inc.20220—
+2K200913Clearblue® Early Digital Pregnancy TestSpd Swiss Precision Diagnostics GmbH202102
+2K193318Distinct® Early Detection Pregnancy TestACON Laboratories, Inc.20200—
+2K182328VeriClear Digital Early Result Pregnancy TestTrue Diagnostics, Inc.20190—
+2K181551DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test…Runbio Biotech Co.,Ltd20190—
+2K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result…True Diagnostics, Inc.20170—
+2K150022Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test…Guangzhou Wondfo Biotech Co., Ltd.20156—
+3K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…Guangzhou Decheng Biotechnology Co., Ltd.20250—
+3K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.20250—
+3K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…Assure Tech., LLC20250—
+3K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.20240—
+3K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…Guangzhou Decheng Biotechnology Co., Ltd.20240—
+3K234152ACESO Early Pregnancy TestAceso Laboratories, Inc.20240—
+3K232864EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream IINantong Egens Biotechnology Co., Ltd.20240—