FDA 510(k) Application Details - K142985

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K142985
Device Name	Calibrator, Secondary
Applicant	BECKMAN COULTER, INC. 250 S. KREAMER BOULEVARD BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	Eimear Carr Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2014
Decision Date	02/26/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review