FDA 510(k) Application Details - K121397

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K121397
Device Name	Reagent, Occult Blood
Applicant	SEKISUI DIAGNOSTICS, LLC 6659 Top Gun St SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	MARK STAVRO 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	05/09/2012
Decision Date	12/28/2012
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