FDA 510(k) Application Details - K152442

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K152442
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	ABBOTT LABORATORIES 1360 South Loop Road Alameda, CA 94502 US Other 510(k) Applications for this Company
Contact	Sai Sriharshada Tatavarty 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	08/27/2015
Decision Date	12/17/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
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