FDA 510(k) Application Details - K113506

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K113506
Device Name	Reagent, Occult Blood
Applicant	IND DIAGNOSTICS INC. 1629 FOSTERS WAY DELTA, BRITISH COLUMBIA V3M 6S7 CA Other 510(k) Applications for this Company
Contact	KAI LOU 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	11/28/2011
Decision Date	12/19/2012
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