FDA 510(k) Application Details - K171521

Device Classification Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)   More FDA Info for this Device
510(K) Number	K171521
Device Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant	DFI Co., Ltd. 388-25, Gomo-ro, Jillye-myeon, Gimhae-si Gyeongsangnam-do 621-881 KR Other 510(k) Applications for this Company
Contact	Bella Cho Other 510(k) Applications for this Contact
Regulation Number	862.1340   More FDA Info for this Regulation Number
Classification Product Code	JIL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2017
Decision Date	02/16/2018
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