AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

AgaMatrix, Inc.

The following data is part of a premarket notification filed by Agamatrix, Inc. with the FDA for Agamatrix Jazz Wireless 2 Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK152365
510k NumberK152365
Device Name:AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant AgaMatrix, Inc. 7C Raymond Avenue Salem,  NH  03079
ContactDavid Olsen
CorrespondentDavid Olsen
AgaMatrix, Inc. 7C Raymond Avenue Salem,  NH  03079
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-21
Decision Date2016-04-21
Summary:summary

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