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

    EQUIPMENT/MATERIAL DECONTAMINATING KIT

    K Number: K911299 · Decision Apr 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    24
    Applicant Total
    4
    Review Days
    14

    Basic Information

    Device Name
    EQUIPMENT/MATERIAL DECONTAMINATING KIT
    K Number
    K911299
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    ROHM AND HAAS CO.
    Date Received
    March 25, 1991
    Decision Date
    April 8, 1991
    Product Code
    KIE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KIE Apparatus, High Pressure Liquid Chromatography

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