FDA 510(k) Application Details - K070486

Device Classification Name	Immunochemical, Bence-Jones Protein   More FDA Info for this Device
510(K) Number	K070486
Device Name	Immunochemical, Bence-Jones Protein
Applicant	Sebia, Inc. 1705 CORPORATE DR. 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	02/20/2007
Decision Date	12/21/2007
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