ORAcollect®•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 Oracollect®•dx.

Pre-market Notification Details

Device IDK212745
510k NumberK212745
Device Name:ORAcollect®•Dx
ClassificationDna Specimen Collection, Saliva
Applicant DNA Genotek Inc 3000 - 500 Palladium Drive Ottawa,  CA K2V 1C2
ContactAustin Udocor
CorrespondentJonathan Chan
DNA Genotek Inc 3000 - 500 Palladium Drive Ottawa,  CA K2V 1C2
Product CodeOYJ  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-30
Decision Date2022-10-27

Trademark Results [ORAcollect]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORACOLLECT
ORACOLLECT
85375308 4669396 Live/Registered
DNA Genotek Inc.
2011-07-19

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