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

    BILE ACIDS REAGENT SET

    K Number: K970120 · Decision Mar 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    51
    Review Days
    69

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    Basic Information

    Device Name
    BILE ACIDS REAGENT SET
    K Number
    K970120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1177
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Teco Diagnostics
    Date Received
    January 14, 1997
    Decision Date
    March 24, 1997
    Product Code
    KWW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KWW Radioimmunoassay, Cholyglycine, Bile Acids

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