BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System

    K Number: K152365 · Decision Apr 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    7
    Review Days
    244

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    Basic Information

    Device Name
    AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
    K Number
    K152365
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Agamatrix, Inc.
    Date Received
    August 21, 2015
    Decision Date
    April 21, 2016
    Product Code
    NBW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NBW System, Test, Blood Glucose, Over The Counter

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    Other Clearances by Agamatrix, Inc.

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    K103544 IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
    K083265 JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
    K052762 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067