ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Accu-chek Aviva Connect Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK141867
510k NumberK141867
Device Name:ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
ContactKhone Saysana
CorrespondentKhone Saysana
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-10
Decision Date2015-03-03
Summary:summary

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