FDA 510(k) Application Details - K051806

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K051806
Device Name	Reagent, Occult Blood
Applicant	EPITOPE DIAGNOSTICS, INC. 7955 DUNBROOK RD., SUITE B SAN DIEGO, CA 92126 US Other 510(k) Applications for this Company
Contact	PING GAO 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	07/05/2005
Decision Date	10/03/2005
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	N
Expedited Review