FDA 510(k) Application Details - K024210

Device Classification Name	Ige, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K024210
Device Name	Ige, Antigen, Antiserum, Control
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 BREA, CA 92822 US Other 510(k) Applications for this Company
Contact	ANNETTE HELLIE Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	DGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2002
Decision Date	02/24/2003
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