FDA 510(k) K152556, Oragene Dx, by DNA Genotek, Inc.

510(K) Number: K152556
Device Name: Oragene Dx
Manufacturer: DNA Genotek, Inc.
Device Classification Name: dna specimen collection, saliva
Regulation Number: 862.1675
Classification Product Code: OYJ
Date Received: 09/08/2015
Decision Date: 05/26/2016
Regulation Medical Specialty: Clinical Chemistry