AncestryDNA Saliva Collection Kit

Dna Specimen Collection, Saliva

Ancestry Genomics, Inc.

The following data is part of a premarket notification filed by Ancestry Genomics, Inc. with the FDA for Ancestrydna Saliva Collection Kit.

Pre-market Notification Details

Device IDK192947
510k NumberK192947
Device Name:AncestryDNA Saliva Collection Kit
ClassificationDna Specimen Collection, Saliva
Applicant Ancestry Genomics, Inc. 153 Townsend Street, Suite 800 San Francisco,  CA  94107
ContactRaajdeep Venkatesan
CorrespondentRaajdeep Venkatesan
Ancestry Genomics, Inc. 153 Townsend Street, Suite 800 San Francisco,  CA  94107
Product CodeOYJ  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-18
Decision Date2020-08-13

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