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

    OLYMPUS URINE PH

    K Number: K905146 · Decision Feb 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    14
    Review Days
    81

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    Basic Information

    Device Name
    OLYMPUS URINE PH
    K Number
    K905146
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Systems
    Date Received
    November 15, 1990
    Decision Date
    February 4, 1991
    Product Code
    JQY
    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
    JQY Ph Meter

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