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

    SYN ELISA DSDNA ANTIBODIES

    K Number: K921132 · Decision Dec 1, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    49
    Applicant Total
    54
    Review Days
    266

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    Basic Information

    Device Name
    SYN ELISA DSDNA ANTIBODIES
    K Number
    K921132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elias U.S.A., Inc.
    Date Received
    March 10, 1992
    Decision Date
    December 1, 1992
    Product Code
    LKJ
    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
    LKJ Antinuclear Antibody, Antigen, Control

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