510(k) Report

Devices descending from K122907

1 later device reach Fastep at-Home Pregnancy, HCG, Over the Counter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamAssure Tech. (Hangzhou) Co, Ltd.20240—