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

    COLUMNS LIQUID CHROMATOGRAPHY DPM

    K Number: K905538 · Decision Jan 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    45

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    Basic Information

    Device Name
    COLUMNS LIQUID CHROMATOGRAPHY DPM
    K Number
    K905538
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Millpore Corp.
    Date Received
    December 11, 1990
    Decision Date
    January 25, 1991
    Product Code
    KZR
    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
    KZR Chromatography (Liquid, Gel), Clinical Use

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