FDA 510(k) Application Details - K181915

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K181915
Device Name	Assay, Glycosylated Hemoglobin
Applicant	iXensor Co., LTD. 6F., No.9 Aly. 2, Ln. 35, Jihu Road. Neihu Dist. Taipei 114 TW Other 510(k) Applications for this Company
Contact	Ariel Huang 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	07/17/2018
Decision Date	04/12/2019
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