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510(k) K192947

Device
AncestryDNA Saliva Collection Kit
Applicant
Ancestry Genomics, Inc.
510(k) number
K192947
Product code
OYJ  
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-13
Date received
2019-10-18
Regulation
862.1675
Classification name
Dna Specimen Collection, Saliva
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Raajdeep Venkatesan
Address
153 Townsend St., Suite 800 San Francisco CA US 94107 94107

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OYJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K212745ORAcollect®•DxDNA Genotek, Inc.2022-10-27
K192920Oragene®•DxDNA Genotek, Inc.2020-01-14
K152464ORAcollect.DxDNA Genotek, Inc.2016-05-26
K152556Oragene DxDNA Genotek, Inc.2016-05-26
K141410ORAGENE DX OGD-500.001DNA Genotek, Inc.2015-02-19
K110701ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500DNA Genotek, Inc.2011-12-02

Legacy Summary#

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FDA Review#

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