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

    ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS

    K Number: K992163 · Decision Jul 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    18

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    Basic Information

    Device Name
    ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
    K Number
    K992163
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.2860
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pdz-Europa , Ltd.
    Date Received
    June 25, 1999
    Decision Date
    July 13, 1999
    Product Code
    DOP
    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
    DOP Mass Spectrometer, Clinical Use

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