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

    MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM)

    K Number: K884923 · Decision Jan 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    265
    Applicant Total
    321
    Review Days
    47

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    Basic Information

    Device Name
    MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM)
    K Number
    K884923
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Products Corp.
    Date Received
    November 25, 1988
    Decision Date
    January 11, 1989
    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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