510(k) Report

Devices descending from K123567

2 later devices reach First Response Gold Digital Pregnancy Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200913Clearblue® Early Digital Pregnancy TestSpd Swiss Precision Diagnostics GmbH202102
+1K182328VeriClear Digital Early Result Pregnancy TestTrue Diagnostics, Inc.20190—