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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna Specimen Collection, Saliva
510(k) Number K192947
Device Name AncestryDNA Saliva Collection Kit
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 Raajdeep Venkatesan
Regulation Number862.1675
Classification Product Code
OYJ  
Date Received10/18/2019
Decision Date 08/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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