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

    QM300 PREALBUMIN ANTIBODY PACK

    K Number: K883002 · Decision Sep 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    10
    Applicant Total
    58
    Review Days
    66

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    Basic Information

    Device Name
    QM300 PREALBUMIN ANTIBODY PACK
    K Number
    K883002
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5060
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Diag, A Div. of Erbamont, Inc.
    Date Received
    July 18, 1988
    Decision Date
    September 22, 1988
    Product Code
    JZJ
    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
    JZJ Prealbumin, Antigen, Antiserum, Control

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