510(k) Report

Devices descending from K914253

3 later devices reach Proclinic One Step Pregnancy Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K960733Ministick Pregnancy TestVanguard Biomedical Corp.19962—
+2K172512ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc.20181—
+3K180771Acro HCG Pregnancy Rapid TestAcro Biotech, Inc.20180—