FDA 510(k) Application Details - K051122

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K051122
Device Name	Counter, Differential Cell
Applicant	BECKMAN COULTER, INC. 7330 CARROLL RD. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	MARA CALER 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	05/02/2005
Decision Date	08/01/2005
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