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

    TREP-SURE TREPONEMAL ANTIBODY EIA

    K Number: K053570 · Decision Aug 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    228

    Basic Information

    Device Name
    TREP-SURE TREPONEMAL ANTIBODY EIA
    K Number
    K053570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    PHOENIX BIOTECH CORP.
    Date Received
    December 22, 2005
    Decision Date
    August 7, 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 PHOENIX BIOTECH CORP.

    K Number Device Name
    K001552 TREPCHEK TREPONEMAL ANTIBODY EIA