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

    ENZY-WELL SYPHILIS IGG, MODEL 91106

    K Number: K050590 · Decision Aug 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    520

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    Basic Information

    Device Name
    ENZY-WELL SYPHILIS IGG, MODEL 91106
    K Number
    K050590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diesse Diagnostica Senese S.P.A.
    Date Received
    March 8, 2005
    Decision Date
    August 10, 2006
    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 Diesse Diagnostica Senese S.P.A.

    K Number Device Name
    K070062 COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE