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

    AYNELISA M2-ANTIBODIES

    K Number: K930143 · Decision May 11, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    26
    Applicant Total
    54
    Review Days
    119

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    Basic Information

    Device Name
    AYNELISA M2-ANTIBODIES
    K Number
    K930143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5090
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elias U.S.A., Inc.
    Date Received
    January 12, 1993
    Decision Date
    May 11, 1993
    Product Code
    DBM
    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
    DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

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