FDA 510(k)

AncestryDNA Saliva Collection Kit

K-Number: K192947 · 2020-08-13

Decision Date2020-08-13

Product CodeOYJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AncestryDNA Saliva Collection Kit 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 K192947. The device is classified under product code OYJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AncestryDNA Saliva Collection Kit?

AncestryDNA Saliva Collection Kit 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 K192947.

When did AncestryDNA Saliva Collection Kit receive FDA 510(k) clearance?

AncestryDNA Saliva Collection Kit received FDA 510(k) clearance on 2020-08-13, under 510(k) number K192947.

Who is the listed applicant for AncestryDNA Saliva Collection Kit?

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 Saliva Collection Kit?

The FDA product code for AncestryDNA Saliva Collection Kit is OYJ.

Other records listing Ancestry Genomics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192944AncestryDNA Factor V Leiden Genetic Health Risk Test

Related Devices (Code: OYJ)

K212745ORAcollect®•DxDNA Genotek, Inc.K192920Oragene®•DxDNA Genotek, Inc.K152556Oragene DxDNA Genotek, Inc.K152464ORAcollect.DxDNA Genotek, Inc.

Official Source

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