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

    TRIGLYCERIDES LCK 124

    K Number: K853041 · Decision Aug 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    24

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    Basic Information

    Device Name
    TRIGLYCERIDES LCK 124
    K Number
    K853041
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1795
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    German American Chamber of Commerce, Inc.
    Date Received
    July 19, 1985
    Decision Date
    August 12, 1985
    Product Code
    CDF
    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
    CDF Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

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