FDA 510(k) Application Details - K050202

Device Classification Name	Radioimmunoassay, Cortisol   More FDA Info for this Device
510(K) Number	K050202
Device Name	Radioimmunoassay, Cortisol
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	BRENT TABER Other 510(k) Applications for this Contact
Regulation Number	862.1205   More FDA Info for this Regulation Number
Classification Product Code	CGR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2005
Decision Date	02/09/2005
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