FDA 510(k) Application Details - K113726

Device Classification Name	Electrode, Ion Based, Enzymatic, Creatinine   More FDA Info for this Device
510(K) Number	K113726
Device Name	Electrode, Ion Based, Enzymatic, Creatinine
Applicant	EPOCAL, INC. 2060 WALKLEY RD. OTTAWA, ONTARIO K1G-3P5 CA Other 510(k) Applications for this Company
Contact	ROY LAYER Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	CGL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2011
Decision Date	10/05/2012
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