FDA 510(k) Application Details - K013235

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K013235
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 BREA, CA 92822 US Other 510(k) Applications for this Company
Contact	MARY BETH TANG Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2001
Decision Date	10/16/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review