FDA 510(k) Application Details - K073490

Device Classification Name	Method, Nephelometric, Immunoglobulins (G, A, M)   More FDA Info for this Device
510(K) Number	K073490
Device Name	Method, Nephelometric, Immunoglobulins (G, A, M)
Applicant	OLYMPUS AMERICA INC. LISMEEHAN, O, CALLAGHAN'S MILLS CO. CLARE IE Other 510(k) Applications for this Company
Contact	STEPHANIE G DONNELLY Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	CFN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2007
Decision Date	02/11/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review