FDA 510(k) Application Details - K092505

Device Classification Name	Ferritin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K092505
Device Name	Ferritin, Antigen, Antiserum, Control
Applicant	BECKMAN COULTER, INC. LISMEEHAN, O'CALLAGHAN'S MILLS CO. CLARE IE Other 510(k) Applications for this Company
Contact	CATRIONA NEILAN Other 510(k) Applications for this Contact
Regulation Number	866.5340   More FDA Info for this Regulation Number
Classification Product Code	DBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2009
Decision Date	12/11/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review