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

    INCSTAR'S DANDELION ALLERGEN DISC

    K Number: K880187 · Decision Apr 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    265
    Applicant Total
    58
    Review Days
    97

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    Basic Information

    Device Name
    INCSTAR'S DANDELION ALLERGEN DISC
    K Number
    K880187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Incstar Corp.
    Date Received
    January 15, 1988
    Decision Date
    April 21, 1988
    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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