FDA 510(k) Application Details - K081249

Device Classification Name	Alpha-2-Macroglobulin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K081249
Device Name	Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Applicant	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	ANNA MARIE KATHLEEN ENNIS Other 510(k) Applications for this Contact
Regulation Number	866.5620   More FDA Info for this Regulation Number
Classification Product Code	DEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2008
Decision Date	07/21/2008
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