FDA 510(k) Application Details - K092330

Device Classification Name	Automated Occult Blood Analyzer   More FDA Info for this Device
510(K) Number	K092330
Device Name	Automated Occult Blood Analyzer
Applicant	EIKEN CHEMICAL CO., LTD. 4-19-9, TAITO, TAITO-KU TOKYO 110-8408 JP Other 510(k) Applications for this Company
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	08/04/2009
Decision Date	01/08/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review