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

    TEST, BLOOD GLUCOSE SYSTEM

    K Number: K120064 · Decision Sep 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    10
    Review Days
    240

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    Basic Information

    Device Name
    TEST, BLOOD GLUCOSE SYSTEM
    K Number
    K120064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hmd Biomedical, Inc.
    Date Received
    January 9, 2012
    Decision Date
    September 5, 2012
    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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