FDA 510(k) Application Details - K151566

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K151566
Device Name	Calibrator, Secondary
Applicant	ABBOTT LABORATORIES 100 Abbott Park Road Dept. 09VA, AP08 Abbott Park, IL 60064 US Other 510(k) Applications for this Company
Contact	Lisa Lukowski 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	06/10/2015
Decision Date	07/10/2015
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