510(k) K132511

FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM by Abbott Diabetes Care, Inc. — Product Code NBW

K132511 is an FDA 510(k) premarket notification submitted by Abbott Diabetes Care, Inc. for the device "FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 24, 2013. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Abbott Diabetes Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2013
Date Received
August 12, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type