Oragene®•Dx

Dna Specimen Collection, Saliva

DNA Genotek Inc.

The following data is part of a premarket notification filed by Dna Genotek Inc. with the FDA for Oragene®•dx.

Pre-market Notification Details

Device IDK192920
510k NumberK192920
Device Name:Oragene®•Dx
ClassificationDna Specimen Collection, Saliva
Applicant DNA Genotek Inc. 3000 - 500 Palladium Drive Ottawa,  CA K2v 1c2
ContactAustin Udocor
CorrespondentAustin Udocor
DNA Genotek Inc. 3000 - 500 Palladium Drive Ottawa,  CA K2v 1c2
Product CodeOYJ  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-16
Decision Date2020-01-14

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