FDA 510(k) Application Details - K082388

Device Classification Name	Immunoelectrophoretic, Immunoglobulins, (G, A, M)   More FDA Info for this Device
510(K) Number	K082388
Device Name	Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Applicant	SEBIA 400-1705 CORPORATE DRIVE NORCROSS, GA 30093 US Other 510(k) Applications for this Company
Contact	KAREN ANDERSON Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	CFF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2008
Decision Date	04/14/2009
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