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

    HISTOLOGY PARAFFIN

    K Number: K862141 · Decision Jun 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    9

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    Basic Information

    Device Name
    HISTOLOGY PARAFFIN
    K Number
    K862141
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.4010
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Erie Scientific Co.
    Date Received
    June 4, 1986
    Decision Date
    June 13, 1986
    Product Code
    KEO
    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
    KEO Formulations, Paraffin, All

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