510(k) Report

Devices descending from K012215

3 later devices reach Quik-Check Home Pregnancy Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210341One Step Pregnancy TestSpd Swiss Precision Diagnostics GmbH20220—
+1K131236Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test, Midstream…Ucp Biosciences, Inc.20130—
+1K032661Acon Quick-Check II Home Pregnancy Test Device (Cassette)ACON Laboratories, Inc.20030—