BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LIGHTNING DIALYZER

    K Number: K810871 · Decision Jul 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    101

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    Basic Information

    Device Name
    LIGHTNING DIALYZER
    K Number
    K810871
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5065
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Clintox Laboratories, Inc.
    Date Received
    March 31, 1981
    Decision Date
    July 10, 1981
    Product Code
    DHY
    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
    DHY Ng4m(A), Antigen, Antiserum, Control