FDA 510(k) Application Details - K062924

Device Classification Name	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K062924
Device Name	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	PAMELA A JURGA Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	NQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2006
Decision Date	12/26/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review