BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MINISTAT-S CHEMISTRY ANALYZER

    K Number: K771591 · Decision Sep 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    32

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    Basic Information

    Device Name
    MINISTAT-S CHEMISTRY ANALYZER
    K Number
    K771591
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2500
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biokinetix Corp.
    Date Received
    August 19, 1977
    Decision Date
    September 20, 1977
    Product Code
    JJI
    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
    JJI Analyzer, Enzyme, For Clinical Use

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