FDA 510(k) Application Details - K132399

Device Classification Name	Enzymatic Method, Creatinine   More FDA Info for this Device
510(K) Number	K132399
Device Name	Enzymatic Method, Creatinine
Applicant	ELITECH GROUP 21720 23RD DR S.E., SUITE 150 BOTHELL, WA 98021 US Other 510(k) Applications for this Company
Contact	DEBRA K HUTSON Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	JFY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2013
Decision Date	01/03/2014
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