510(k) Report

Devices descending from K974059

2 later devices reach One Step Midstream HCG Pregnancy Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122907Fastep at-Home Pregnancy, HCG, Over the CounterPolymed Therapeutics, Inc.20131—
+2K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamAssure Tech. (Hangzhou) Co, Ltd.20240—