510(k) Report

Devices descending from DEN160026

3 later devices reach Genetic Variant Detection And Health Risk Assessment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221420AlphaID™ At Home Genetic Health Risk ServiceProgenika Biopharma S.A., A Grifols Company20220—
+1K192073Helix Genetic Health Risk App for late-onset Alzheimer’s diseaseHelix Opco, LLC20200—
+1K192944AncestryDNA Factor V Leiden Genetic Health Risk TestAncestry Genomics, Inc.20200—