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

    OSMOTIC PRESSURE AUTO & STAT OM-6010

    K Number: K842750 · Decision Aug 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    11
    Applicant Total
    11
    Review Days
    35

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    Basic Information

    Device Name
    OSMOTIC PRESSURE AUTO & STAT OM-6010
    K Number
    K842750
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2730
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Kyoto Diagnostics, Inc.
    Date Received
    July 13, 1984
    Decision Date
    August 17, 1984
    Product Code
    JJM
    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
    JJM Osmometer For Clinical Use

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