FDA 510(k) Application Details - K060463

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K060463
Device Name	Reagent, Occult Blood
Applicant	IMMUNOSTICS, INC. 3505 SUNSET AVE. OCEAN, NJ 07712 US Other 510(k) Applications for this Company
Contact	JEFFREY FLEISHMAN 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	02/22/2006
Decision Date	06/06/2006
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