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

    TRI-CON TRIGLYCERIDGE REAGENTS

    K Number: K761283 · Decision Feb 24, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    21
    Applicant Total
    44
    Review Days
    66

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    Basic Information

    Device Name
    TRI-CON TRIGLYCERIDGE REAGENTS
    K Number
    K761283
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1705
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Dade, Baxter Travenol Diagnostics, Inc.
    Date Received
    December 20, 1976
    Decision Date
    February 24, 1977
    Product Code
    JGY
    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
    JGY Colorimetric Method, Triglycerides

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