510(k) K171941

FreeStyle Precision Neo Blood Glucose Test Strips by Abbott Diabetes Care, Inc. — Product Code NBW

K171941 is an FDA 510(k) premarket notification submitted by Abbott Diabetes Care, Inc. for the device "FreeStyle Precision Neo Blood Glucose Test Strips". The FDA issued a decision of Substantially Equivalent on September 27, 2017. 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
September 27, 2017
Date Received
June 28, 2017
Clearance Type
Traditional
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