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

    IMMULIK STAIN PLATE

    K Number: K812497 · Decision Sep 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    0
    Applicant Total
    15
    Review Days
    23

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    Basic Information

    Device Name
    IMMULIK STAIN PLATE
    K Number
    K812497
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.3010
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Immulok, Inc.
    Date Received
    August 31, 1981
    Decision Date
    September 23, 1981
    Product Code
    IEG
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IEG Table, Slide Warming

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