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

    GUAMSTAINER

    K Number: K811697 · Decision Jul 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    20
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    GUAMSTAINER
    K Number
    K811697
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.3800
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Tomtec
    Date Received
    June 16, 1981
    Decision Date
    July 2, 1981
    Product Code
    KPA
    Advisory Committee
    Pathology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPA Slide Stainer, Automated

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