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

    NOVA 11 NA/K/LI ANALYZER

    K Number: K915178 · Decision Jan 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    88
    Applicant Total
    89
    Review Days
    73

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    Basic Information

    Device Name
    NOVA 11 NA/K/LI ANALYZER
    K Number
    K915178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1600
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nova Biomedical Corp.
    Date Received
    November 15, 1991
    Decision Date
    January 27, 1992
    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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