FDA 510(k) Application Details - K100489

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K100489
Device Name	Counter, Differential Cell
Applicant	BECKMAN COULTER CELLULAR 11800 SW 147 AVENUE MS 31 BO6 MIAMI, FL 33196-2500 US Other 510(k) Applications for this Company
Contact	JEANNE ROSCOE Other 510(k) Applications for this Contact
Regulation Number	864.5220   More FDA Info for this Regulation Number
Classification Product Code	GKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2010
Decision Date	10/26/2010
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