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 IDK152556
510k NumberK152556
Device Name:Oragene Dx
ClassificationDna Specimen Collection, Saliva
Applicant DNA Genotek Inc 2 Beaverbrook Road Ottawa,  CA K2k 1l1
ContactDan Fullerton
CorrespondentDan Fullerton
DNA Genotek Inc 2 Beaverbrook Road Ottawa,  CA K2k 1l1
Product CodeOYJ  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-08
Decision Date2016-05-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00627595000262 K152556 000
00627595000255 K152556 000
00627595000248 K152556 000
00627595000132 K152556 000

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