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

    ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT

    K Number: K803296 · Decision Jan 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    37
    Review Days
    17

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    Basic Information

    Device Name
    ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT
    K Number
    K803296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1177
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Immunotech Corp.
    Date Received
    December 30, 1980
    Decision Date
    January 16, 1981
    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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