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FDA 510(k)

AncestryDNA Factor V Leiden Genetic Health Risk Test

K-Number: K192944 · 2020-08-13

ApplicantAncestry Genomics, Inc.
Decision Date2020-08-13
Product CodePTA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AncestryDNA Factor V Leiden Genetic Health Risk Test is the device name listed in this FDA 510(k) record. The listed applicant is Ancestry Genomics, Inc.. It received FDA 510(k) clearance on 2020-08-13 under 510(k) number K192944. The device is classified under product code PTA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AncestryDNA Factor V Leiden Genetic Health Risk Test?

AncestryDNA Factor V Leiden Genetic Health Risk Test is a medical device that received FDA 510(k) clearance on 2020-08-13. The listed applicant is Ancestry Genomics, Inc.. The 510(k) number is K192944.

When did AncestryDNA Factor V Leiden Genetic Health Risk Test receive FDA 510(k) clearance?

AncestryDNA Factor V Leiden Genetic Health Risk Test received FDA 510(k) clearance on 2020-08-13, under 510(k) number K192944.

Who is the listed applicant for AncestryDNA Factor V Leiden Genetic Health Risk Test?

The FDA 510(k) record lists Ancestry Genomics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AncestryDNA Factor V Leiden Genetic Health Risk Test?

The FDA product code for AncestryDNA Factor V Leiden Genetic Health Risk Test is PTA.

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Other records listing Ancestry Genomics, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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