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

    OSMOLARITY STANDARDS

    K Number: K844589 · Decision Mar 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    95

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    Basic Information

    Device Name
    OSMOLARITY STANDARDS
    K Number
    K844589
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1540
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Rna Medical Corp.
    Date Received
    November 26, 1984
    Decision Date
    March 1, 1985
    Product Code
    JMZ
    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
    JMZ Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality

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