FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM

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 Connect Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK051802
510k NumberK051802
Device Name:FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda,  CA  94502
ContactKimberley Kline
CorrespondentKimberley Kline
ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda,  CA  94502
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-05
Decision Date2005-08-09
Summary:summary

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