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

    TURBO-RAST SPECIFIC IGE ASSAY

    K Number: K903000 · Decision Jul 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    8
    Applicant Total
    82
    Review Days
    22

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    Basic Information

    Device Name
    TURBO-RAST SPECIFIC IGE ASSAY
    K Number
    K903000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Ventrex Laboratories, Inc.
    Date Received
    July 9, 1990
    Decision Date
    July 31, 1990
    Product Code
    JHR
    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
    JHR Radioimmunoassay, Immunoglobulins (D, E)

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