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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