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510(k) K192920

Oragene®Dx by DNA Genotek, Inc. — Product Code OYJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 14, 2020
Date Received: October 16, 2019
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.