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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna Specimen Collection, Saliva
510(k) Number K192920
Device Name Oragene®•Dx
Applicant
Dna Genotek, Inc.
3000-500 Palladium Dr.
Ottawa,  CA K2V 1C2
Applicant Contact Austin Udocor
Correspondent
Dna Genotek, Inc.
3000-500 Palladium Dr.
Ottawa,  CA K2V 1C2
Correspondent Contact Austin Udocor
Regulation Number862.1675
Classification Product Code
OYJ  
Date Received10/16/2019
Decision Date 01/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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