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

    XYLENE

    K Number: K812847 · Decision Oct 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    14
    Applicant Total
    33
    Review Days
    20

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    Basic Information

    Device Name
    XYLENE
    K Number
    K812847
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.4010
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Richard-Allan Medical Ind., Inc.
    Date Received
    October 9, 1981
    Decision Date
    October 29, 1981
    Product Code
    KEM
    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
    KEM Agent, Clearing

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