FDA 510(k) Application Details - K130265

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K130265
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	BAYER HEALTHCARE LLC 430 S BEIGER ST MISHAWAKA, IN 46544 US Other 510(k) Applications for this Company
Contact	JENNIFER GREGORY Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	NBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2013
Decision Date	06/23/2014
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