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

    LIPASE REAGENT SET (COLIPASE METHOD)

    K Number: K970124 · Decision Mar 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    51
    Review Days
    51

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    Basic Information

    Device Name
    LIPASE REAGENT SET (COLIPASE METHOD)
    K Number
    K970124
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1465
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Teco Diagnostics
    Date Received
    January 14, 1997
    Decision Date
    March 6, 1997
    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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