FDA 510(k) Application Details - K162208

Device Classification Name	Method, Nephelometric, Immunoglobulins (G, A, M)   More FDA Info for this Device
510(K) Number	K162208
Device Name	Method, Nephelometric, Immunoglobulins (G, A, M)
Applicant	BECKMAN COULTER INC. 250 S. KRAEMER BLVD. MAIL STOP E1.SE.01 BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	Geraldine Fuentespina Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	CFN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2016
Decision Date	01/09/2017
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