FDA 510(k) Application Details - K060930

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K060930
Device Name	Reagent, Occult Blood
Applicant	ENTERIX INC. 236 FERNWOOD AVE. EDISON, NJ 08837 US Other 510(k) Applications for this Company
Contact	EDWIN DIAZ 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	04/05/2006
Decision Date	05/04/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review