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

    KETO-340 II

    K Number: K912373 · Decision Jul 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    23
    Applicant Total
    5
    Review Days
    33

    Basic Information

    Device Name
    KETO-340 II
    K Number
    K912373
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1435
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    IHARA MEDICS U.S., INC.
    Date Received
    May 29, 1991
    Decision Date
    July 1, 1991
    Product Code
    JIN
    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
    JIN Nitroprusside, Ketones (Urinary, Non-Quant.)

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    Other Clearances by IHARA MEDICS U.S., INC.

    K Number Device Name
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