FDA 510(k) Application Details - K111023

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K111023
Device Name	Calibrator, Secondary
Applicant	ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT 9V6, AP5N-2 ABBOTT PARK, IL 60064 US Other 510(k) Applications for this Company
Contact	JOHN RIZOS Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2011
Decision Date	06/10/2011
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