IWL2020 Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

Roche Diabetes Care Inc.

The following data is part of a premarket notification filed by Roche Diabetes Care Inc. with the FDA for Iwl2020 Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK203711
510k NumberK203711
Device Name:IWL2020 Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Roche Diabetes Care Inc. 9115 Hague Road Indianapolis,  IN  46250 -0457
ContactKelly Brennan
CorrespondentKelly Brennan
Roche Diabetes Care Inc. 9115 Hague Road Indianapolis,  IN  46250 -0457
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-21
Decision Date2022-05-06

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