FDA 510(k) Application Details - K072612

Device Classification Name	System, Test, Immunological, Antigen, Tumor   More FDA Info for this Device
510(K) Number	K072612
Device Name	System, Test, Immunological, Antigen, Tumor
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	RACHELLE PARSONS Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	MOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2007
Decision Date	10/26/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review