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

    LKB-BROMMA 2188 ULTROTOME NOVA

    K Number: K812158 · Decision Sep 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    52
    Review Days
    49

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    Basic Information

    Device Name
    LKB-BROMMA 2188 ULTROTOME NOVA
    K Number
    K812158
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.3010
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Lkb Instruments, Inc.
    Date Received
    July 29, 1981
    Decision Date
    September 16, 1981
    Product Code
    IDM
    Advisory Committee
    Pathology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IDM Microtome, Ultra

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