FDA 510(k) Application Details - K110701

Device Classification Name	More FDA Info for this Device
510(K) Number	K110701
Device Name	ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
Applicant	DNA GENOTEK INC 2 BEAVERBROOK ROAD OTTAWA ONTARIO K2K 1L1 CA Other 510(k) Applications for this Company
Contact	CHANTAL HEMENS-DAVIS 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	03/14/2011
Decision Date	12/02/2011
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