BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ESCHWEILER COMBI-ANALYSER MTA-500

    K Number: K840961 · Decision Aug 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    87
    Applicant Total
    1
    Review Days
    157

    Basic Information

    Device Name
    ESCHWEILER COMBI-ANALYSER MTA-500
    K Number
    K840961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1600
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    U.S. SCIENCE, INC.
    Date Received
    March 6, 1984
    Decision Date
    August 10, 1984
    Product Code
    CEM
    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
    CEM Electrode, Ion Specific, Potassium

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