FDA 510(k) Application Details - K081161

Device Classification Name	Method, Nephelometric, Immunoglobulins (G, A, M)   More FDA Info for this Device
510(K) Number	K081161
Device Name	Method, Nephelometric, Immunoglobulins (G, A, M)
Applicant	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714-6101 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	04/24/2008
Decision Date	07/28/2008
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