FDA 510(k) Application Details - K060774

Device Classification Name	Acid, Folic, Radioimmunoassay   More FDA Info for this Device
510(K) Number	K060774
Device Name	Acid, Folic, Radioimmunoassay
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	CAROLYN ANDERSON Other 510(k) Applications for this Contact
Regulation Number	862.1295   More FDA Info for this Regulation Number
Classification Product Code	CGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2006
Decision Date	04/21/2006
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