FDA 510(k) Application Details - K052223

Device Classification Name	Assay, Erythropoietin   More FDA Info for this Device
510(K) Number	K052223
Device Name	Assay, Erythropoietin
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	LYNN WEIST Other 510(k) Applications for this Contact
Regulation Number	864.7250   More FDA Info for this Regulation Number
Classification Product Code	GGT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2005
Decision Date	10/06/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review