BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT

    K Number: K896585 · Decision Dec 4, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    86
    Applicant Total
    39
    Review Days
    13

    Basic Information

    Device Name
    MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
    K Number
    K896585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    MEDIX BIOTECH, INC.
    Date Received
    November 21, 1989
    Decision Date
    December 4, 1989
    Product Code
    DBF
    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
    DBF Ferritin, Antigen, Antiserum, Control

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