FDA 510(k) Application Details - K173127

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K173127
Device Name	Assay, Glycosylated Hemoglobin
Applicant	Skyla Corporation H.S.P.B. 1f. No. 8, Dusing Rd., Hsinchu Science Park Hsinchu 30078 TW Other 510(k) Applications for this Company
Contact	Cindy Lu 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	09/29/2017
Decision Date	09/25/2018
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