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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 K141410
FOIA Releasable 510(k) K141410
Device Name ORAGENE DX OGD-500.001
Applicant
DNA GENOTEK, INC.
2 BEAVERBROOK ROAD
OTTAWA,  CA K2K 1L1
Applicant Contact DAN FULLERTON
Correspondent
DNA GENOTEK, INC.
2 BEAVERBROOK ROAD
OTTAWA,  CA K2K 1L1
Correspondent Contact DAN FULLERTON
Regulation Number862.1675
Classification Product Code
OYJ  
Date Received05/29/2014
Decision Date 02/19/2015
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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