FDA 510(k) Application Details - K080812

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K080812
Device Name	Reagent, Occult Blood
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 PO BOX 8000 BREA, CA 92822 US Other 510(k) Applications for this Company
Contact	SYLVIA ZORICH 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	03/24/2008
Decision Date	06/25/2008
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