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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    GE333 Blood Glucose Monitoring System

    K Number: K143387 · Decision Jun 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    3
    Review Days
    189

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    Basic Information

    Device Name
    GE333 Blood Glucose Monitoring System
    K Number
    K143387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionime Coporation
    Date Received
    November 26, 2014
    Decision Date
    June 3, 2015
    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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