FDA 510(k) Application Details - K162333

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K162333
Device Name	Reagent, Occult Blood
Applicant	GUANGZHOU WONDFO BIOTECH CO., LTD. WONDFO SCIENTECH PARK, SOUTH CHINA UNIV. OF TECHNOLOGY GUANGZHOU 510641 CN Other 510(k) Applications for this Company
Contact	Bin Chen Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	KHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2016
Decision Date	05/14/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review