FDA 510(k) Application Details - K080916

Device Classification Name	Immunochemical, Bence-Jones Protein   More FDA Info for this Device
510(K) Number	K080916
Device Name	Immunochemical, Bence-Jones Protein
Applicant	SEBIA 400-1705 CORPORATE DRIVE SUITE 400 NORCROSS, GA 30093 US Other 510(k) Applications for this Company
Contact	KAREN ANDERSON Other 510(k) Applications for this Contact
Regulation Number	866.5150   More FDA Info for this Regulation Number
Classification Product Code	JKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2008
Decision Date	07/01/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review