FDA 510(k) Application Details - K112603

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K112603
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	CINDY MCGUIRE Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2011
Decision Date	11/04/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review