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

    MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER

    K Number: K893838 · Decision Aug 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    77
    Applicant Total
    125
    Review Days
    99

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    Basic Information

    Device Name
    MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
    K Number
    K893838
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    May 24, 1989
    Decision Date
    August 31, 1989
    Product Code
    JQP
    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
    JQP Calculator/Data Processing Module, For Clinical Use

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