Ancestry Genomics, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Ancestry Genomics, Inc. has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ancestry Genomics, Inc." is on file.

What these totals cover: FDA records filed under the name "Ancestry Genomics, Inc." and its spelling variant "Ancestry Genomics".

Latest 510(k)
Aug 13, 2020

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent 510(k) clearances

2 510(k) clearances on Aug 13, 2020.

K-NumberDeviceDate
K192947AncestryDNA Saliva Collection KitAug 13, 2020
K192944AncestryDNA Factor V Leiden Genetic Health Risk TestAug 13, 2020

Ancestry Genomics, Inc. and the FDA: common questions

Has Ancestry Genomics, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Ancestry Genomics, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Ancestry Genomics, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Ancestry Genomics, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

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