FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005

System, Test, Blood Glucose, Over The Counter

ABBOTT DIABETES CARE INC.

The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, And 16005.

Pre-market Notification Details

Device IDK031260
510k NumberK031260
Device Name:FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda,  CA  94502 -7000
ContactDonna K Templeman
CorrespondentDonna K Templeman
ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda,  CA  94502 -7000
Product CodeNBW  
Subsequent Product CodeJJX
Subsequent Product CodeLFR
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-21
Decision Date2003-12-19
Summary:summary

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