DeviceClearance

AncestryDNA Factor V Leiden Genetic Health Risk Test— 510(k) K192944

Substantially Equivalent

Ancestry Genomics, Inc.

FDA 510(k) clearance K192944 for AncestryDNA Factor V Leiden Genetic Health Risk Test, Substantially Equivalent on 2020-08-13. Applicant: Ancestry Genomics, Inc..

Clearance details

Applicant
Ancestry Genomics, Inc.
Product code
Code PTA
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Francisco, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.