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

    IVT SOUTHWEST ALLERGY SCREEN

    K Number: K870625 · Decision May 1, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    261
    Applicant Total
    7
    Review Days
    77

    Basic Information

    Device Name
    IVT SOUTHWEST ALLERGY SCREEN
    K Number
    K870625
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    IN VITRO TECHNOLOGIES, INC.
    Date Received
    February 13, 1987
    Decision Date
    May 1, 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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    Other Clearances by IN VITRO TECHNOLOGIES, INC.

    K Number Device Name
    K914685 866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS
    K904661 IVT RAST TRACER
    K875329 IVT CENTRAL ALLERGY SCREEN
    K875328 IVT WESTERN ALLERGY SCREEN
    K874168 IVT SOUTHEAST ALLERGY SCREEN
    K874169 IVT NORTHEAST ALLERGY SCREEN