Clearance Summary
AncestryDNA Factor V Leiden Genetic Health Risk Test received FDA 510(k) clearance under submission number K192944, sponsored by Ancestry Genomics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2020-08-13.
- Submission: K192944
- Applicant / Sponsor: Ancestry Genomics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5950
- Decision date: 2020-08-13
Classification & Regulation
This clearance is catalogued under FDA product code PTA and 21 CFR 866.5950, within the Immunology review panel as a Class II device.