FDA 510(k) Application Details - K171247

Device Classification Name	Electrode, Ion Specific, Urea Nitrogen   More FDA Info for this Device
510(K) Number	K171247
Device Name	Electrode, Ion Specific, Urea Nitrogen
Applicant	Epocal Inc. 2060 Walkley Road Ottawa K1G 3P5 CA Other 510(k) Applications for this Company
Contact	Jennifer Armstrong Other 510(k) Applications for this Contact
Regulation Number	862.1770   More FDA Info for this Regulation Number
Classification Product Code	CDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2017
Decision Date	01/17/2018
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