FDA 510(k) Application Details - K081641

Device Classification Name	Mixture, Hematology Quality Control   More FDA Info for this Device
510(K) Number	K081641
Device Name	Mixture, Hematology Quality Control
Applicant	BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 MIAMI, FL 33196-2500 US Other 510(k) Applications for this Company
Contact	NANCY NADLER Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	JPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2008
Decision Date	01/16/2009
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