FDA 510(k) Application Details - K152464

Device Classification Name	More FDA Info for this Device
510(K) Number	K152464
Device Name	ORAcollect.Dx
Applicant	DNA GENOTEK INC. 2 BEAVERBROOK ROAD OTTAWA K2K 1L1 CA Other 510(k) Applications for this Company
Contact	Dan Fullerton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2015
Decision Date	05/26/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review