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

    QLIA IMMUNOCHEMISTRY SYSTEM

    K Number: K883349 · Decision Sep 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    13
    Applicant Total
    632
    Review Days
    29

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    Basic Information

    Device Name
    QLIA IMMUNOCHEMISTRY SYSTEM
    K Number
    K883349
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4520
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    August 9, 1988
    Decision Date
    September 7, 1988
    Product Code
    JZT
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JZT Fluorometer

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