BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KALLESTAD ANTISERA TO PHENYTOIN

    K Number: K811775 · Decision Jul 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    92
    Review Days
    17

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    Basic Information

    Device Name
    KALLESTAD ANTISERA TO PHENYTOIN
    K Number
    K811775
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Laboratories, Inc.
    Date Received
    June 23, 1981
    Decision Date
    July 10, 1981
    Product Code
    DLP
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DLP Radioimmunoassay, Diphenylhydantoin

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