FDA 510(k) Application Details - K140827

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K140827
Device Name	Assay, Glycosylated Hemoglobin
Applicant	SD Biosensor, Inc. C-4th & 5th Floor digital Empire Building 980-3 Yeongtong-dong, Yeongtong-gu Suwon-si 443-702 KR Other 510(k) Applications for this Company
Contact	Yeon Park Other 510(k) Applications for this Contact
Regulation Number	864.7470   More FDA Info for this Regulation Number
Classification Product Code	LCP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2014
Decision Date	09/30/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review