BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    VivaChek Blood Glucose and B-Ketone Monitoring System

    K Number: K192957 · Decision Jun 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    23
    Applicant Total
    10
    Review Days
    228

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    Basic Information

    Device Name
    VivaChek Blood Glucose and B-Ketone Monitoring System
    K Number
    K192957
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1435
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vivachek Biotech (Hangzhou) Co., Ltd.
    Date Received
    October 21, 2019
    Decision Date
    June 5, 2020
    Product Code
    JIN
    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
    JIN Nitroprusside, Ketones (Urinary, Non-Quant.)

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