510(k) Report

Devices descending from K150063

1 later device reach One Step hCG Pregnancy Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230741Macro & Micro-Test HCG Pregnancy Test MidstreamJiangsu Macro & Micro-Test Med-Tech Co., Ltd.20230—