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

    TRACE ANALYTICAL REDUCTION GAS ANALYZ

    K Number: K820025 · Decision Feb 15, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    41

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    Basic Information

    Device Name
    TRACE ANALYTICAL REDUCTION GAS ANALYZ
    K Number
    K820025
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2250
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Trace Analytical
    Date Received
    January 5, 1982
    Decision Date
    February 15, 1982
    Product Code
    KZQ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KZQ Chromatography(Gas), Clinical Use

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