FDA 510(k) Application Details - K002799

Device Classification Name	Immunoelectrophoretic, Immunoglobulins, (G, A, M)   More FDA Info for this Device
510(K) Number	K002799
Device Name	Immunoelectrophoretic, Immunoglobulins, (G, A, M)
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	CFF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2000
Decision Date	10/05/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review