FDA 510(k) Application Details - K110413

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K110413
Device Name	Radioassay, Vitamin B12
Applicant	BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD BREA, CA 92822 US Other 510(k) Applications for this Company
Contact	MARINE BOYAJIAN Other 510(k) Applications for this Contact
Regulation Number	862.1810   More FDA Info for this Regulation Number
Classification Product Code	CDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2011
Decision Date	05/11/2011
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