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FDA 510(k) Applications for Medical Device Product Code "OYJ"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K192947
Ancestry Genomics, Inc.
AncestryDNA Saliva Collection Kit
08/13/2020
K212745
DNA Genotek Inc
ORAcollect«òDx
10/27/2022
K152556
DNA Genotek Inc
Oragene Dx
05/26/2016
K110701
DNA GENOTEK INC
ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
12/02/2011
K152464
DNA GENOTEK INC.
ORAcollect.Dx
05/26/2016
K192920
DNA Genotek Inc.
Oragene«òDx
01/14/2020
K141410
DNA GENOTEK, INC.
ORAGENE DX OGD-500.001
02/19/2015
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