BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ENZYGNOST LIPASE TEST

    K Number: K844240 · Decision Feb 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    145
    Review Days
    103

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    Basic Information

    Device Name
    ENZYGNOST LIPASE TEST
    K Number
    K844240
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1465
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    November 1, 1984
    Decision Date
    February 12, 1985
    Product Code
    CET
    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
    CET Olive Oil Emulsion (Turbidimetric), Lipase

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