FDA 510(k) Application Details - K140654

Device Classification Name	More FDA Info for this Device
510(K) Number	K140654
Device Name	Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
Applicant	ABBOTT LABORATORIES 100 ABBOTT PARK ROAD, DEPT. 09V6 AP8 ABBOTT PARK, IL 60064 US Other 510(k) Applications for this Company
Contact	JUDITH R WALLACH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2014
Decision Date	05/22/2015
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