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

    ROTOR

    K Number: K831571 · Decision Jun 30, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    29
    Applicant Total
    28
    Review Days
    45

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    Basic Information

    Device Name
    ROTOR
    K Number
    K831571
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2140
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Scientific Products
    Date Received
    May 16, 1983
    Decision Date
    June 30, 1983
    Product Code
    JJG
    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
    JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

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