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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Genetic Variant Detection And Health Risk Assessment System
510(k) Number K192944
Device Name AncestryDNA Factor V Leiden Genetic Health Risk Test
Applicant
Ancestry Genomics, Inc.
153 Townsend St., Suite 800
San Francisco,  CA  94107
Applicant Contact Raajdeep Venkatesan
Correspondent
Ancestry Genomics, Inc.
153 Townsend St., Suite 800
San Francisco,  CA  94107
Correspondent Contact Shalini Sadda
Regulation Number866.5950
Classification Product Code
PTA  
Date Received10/18/2019
Decision Date 08/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Hematology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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