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

    ELVI NON-ESTERIFIED FATTY ACIDS

    K Number: K792555 · Decision Jan 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    66
    Review Days
    37

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    Basic Information

    Device Name
    ELVI NON-ESTERIFIED FATTY ACIDS
    K Number
    K792555
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1290
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Volu Sol Medical Industries
    Date Received
    December 10, 1979
    Decision Date
    January 16, 1980
    Product Code
    JLH
    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
    JLH Titrimetric, Fatty Acids

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