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

    GOLDENROD ALLERGEN DISC

    K Number: K875163 · Decision Apr 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    261
    Applicant Total
    58
    Review Days
    127

    Basic Information

    Device Name
    GOLDENROD ALLERGEN DISC
    K Number
    K875163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    INCSTAR CORP.
    Date Received
    December 16, 1987
    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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