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

    KEMBLE 405

    K Number: K842894 · Decision Aug 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    139
    Applicant Total
    9
    Review Days
    35

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    Basic Information

    Device Name
    KEMBLE 405
    K Number
    K842894
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2750
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Kemble Instruments, Inc.
    Date Received
    July 23, 1984
    Decision Date
    August 27, 1984
    Product Code
    JQW
    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
    JQW Station, Pipetting And Diluting, For Clinical Use

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