FDA 510(k) Application Details - K070660

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K070660
Device Name	Reagent, Occult Blood
Applicant	ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	MAJID PAJOUH 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	03/09/2007
Decision Date	06/21/2007
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