FDA 510(k) Application Details - K021150

Device Classification Name	Apparatus, Automated Blood Cell Diluting   More FDA Info for this Device
510(K) Number	K021150
Device Name	Apparatus, Automated Blood Cell Diluting
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	LOURDES COBA Other 510(k) Applications for this Contact
Regulation Number	864.5240   More FDA Info for this Regulation Number
Classification Product Code	GKH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2002
Decision Date	06/11/2002
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