BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    VISUWELL SYPHILIS ANTIBODY

    K Number: K932453 · Decision Jul 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    782

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    Basic Information

    Device Name
    VISUWELL SYPHILIS ANTIBODY
    K Number
    K932453
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomira Diagnostics, Inc.
    Date Received
    May 20, 1993
    Decision Date
    July 11, 1995
    Product Code
    LIP
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

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    Other Clearances by Biomira Diagnostics, Inc.

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