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FDA 510(k)

AncestryDNA Saliva Collection Kit

K-Number: K192947 · 2020-08-13

ApplicantAncestry Genomics, Inc.
Decision Date2020-08-13
Product CodeOYJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AncestryDNA Saliva Collection Kit is a medical device manufactured by Ancestry Genomics, Inc.. It received FDA 510(k) clearance on 2020-08-13 under approval 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. It is manufactured by Ancestry Genomics, Inc.. The 510(k) number is K192947.

When was AncestryDNA Saliva Collection Kit approved by the FDA?

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

What company makes AncestryDNA Saliva Collection Kit?

AncestryDNA Saliva Collection Kit is manufactured by Ancestry Genomics, Inc..

What is the FDA product code for AncestryDNA Saliva Collection Kit?

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

Other Devices by Ancestry Genomics, Inc.

K192944AncestryDNA Factor V Leiden Genetic Health Risk Test

Related Devices (Code: OYJ)

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

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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