FDA 510(k) Applications for Medical Device Product Code: PTA ()

FDA 510(k) Applications for Medical Device Product Code "PTA"

FDA 510(k) Number	Applicant	Device Name	Decision Date
DEN160026	23andMe, Inc.	23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia	04/06/2017
K192944	Ancestry Genomics, Inc.	AncestryDNA Factor V Leiden Genetic Health Risk Test	08/13/2020
K192073	Helix OpCo, LLC	Helix Genetic Health Risk App for late-onset AlzheimerÆs disease	12/23/2020
K221420	Progenika Biopharma S.A., a Grifols company	AlphaIDÖ At Home Genetic Health Risk Service	10/27/2022