FDA 510(k) Application Details - K083445

Device Classification Name	Method, Nephelometric, Immunoglobulins (G, A, M)   More FDA Info for this Device
510(K) Number	K083445
Device Name	Method, Nephelometric, Immunoglobulins (G, A, M)
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 NEWARK, DE 19714 US Other 510(k) Applications for this Company
Contact	HELEN M LEE 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	11/21/2008
Decision Date	03/24/2009
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