FDA 510(k) Application Details - K092740

Device Classification Name	Acid, Folic, Radioimmunoassay   More FDA Info for this Device
510(K) Number	K092740
Device Name	Acid, Folic, Radioimmunoassay
Applicant	ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT. 9V6 AP6C-2 ABBOTT PARK, IL 60064 US Other 510(k) Applications for this Company
Contact	DARLA ABANO 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	09/08/2009
Decision Date	03/05/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review