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

Name: FDA 510(k) clearance K192944
Creator: U.S. Food and Drug Administration
Published: 2020-08-13

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.. Device class: 2.

Clearance details

Applicant: Ancestry Genomics, Inc.
Product code: Code PTA
Device class: Class 2
Regulation: 21 CFR 866.5950
Advisory panel: Immunology
Date received: 2019-10-18
Decision date: 2020-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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