FDA 510(k) Application Details - K100031

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K100031
Device Name	Reagent, Occult Blood
Applicant	IND DIAGNOSTIC INC. 1629 FOSTERS WAY DELTA, BC V3M 6S7 CA Other 510(k) Applications for this Company
Contact	JASON PENG 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	01/06/2010
Decision Date	07/19/2010
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