FDA 510(k) Application Details - K161679

Device Classification Name	More FDA Info for this Device
510(K) Number	K161679
Device Name	s LDL-EX SEIKEN
Applicant	DENKA SEIKEN CO., LTD. 1359-I, Kagamida, Kigoshi Gosen 959-1695 JP Other 510(k) Applications for this Company
Contact	Takayoshi Ishii Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PYP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2016
Decision Date	08/18/2017
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