FDA 510(k) Application Details - K161533

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K161533
Device Name	Assay, Glycosylated Hemoglobin
Applicant	BioHermes Co., Ltd 2F, 3F, No 136 Mashan Meiliang Road, Binhu Dist Wuxi JS510 CN Other 510(k) Applications for this Company
Contact	Rao Qiangying 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	06/02/2016
Decision Date	06/16/2017
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