Home / 510(k) Clearances / K141410

510(k) K141410

ORAGENE DX OGD-500.001 by DNA Genotek, Inc. — Product Code OYJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 19, 2015
Date Received: May 29, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Dna Specimen Collection, Saliva
Device Class: Class II
Regulation Number: 862.1675
Review Panel: CH
Submission Type

A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.