FDA 510(k) Application Details - K191147

Device Classification Name	Automated Occult Blood Analyzer   More FDA Info for this Device
510(K) Number	K191147
Device Name	Automated Occult Blood Analyzer
Applicant	Eiken Chemical Co., Ltd. 4-19-9, Taito Taito-ku 110-8408 JP Other 510(k) Applications for this Company
Contact	Tadashi Yasuda Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	OOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2019
Decision Date	01/02/2020
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