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

    MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT

    K Number: K874281 · Decision Dec 18, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    265
    Applicant Total
    39
    Review Days
    59

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    Basic Information

    Device Name
    MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT
    K Number
    K874281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Medix Biotech, Inc.
    Date Received
    October 20, 1987
    Decision Date
    December 18, 1987
    Product Code
    DHB
    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
    DHB System, Test, Radioallergosorbent (Rast) Immunological

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