FDA 510(k) Application Details - K071002

Device Classification Name	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K071002
Device Name	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 BREA, CA 92822-8000 US Other 510(k) Applications for this Company
Contact	TARA VIVIANI 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	04/09/2007
Decision Date	06/21/2007
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