FDA 510(k) Application Details - K161527

Device Classification Name	Enzymatic Method, Creatinine   More FDA Info for this Device
510(K) Number	K161527
Device Name	Enzymatic Method, Creatinine
Applicant	TECO DIAGNOSTICS, INC. 1268 NORTH LAKEVIEW AVENUE ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	XIAOYAN HU 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	06/02/2016
Decision Date	07/21/2017
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