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

    PHENYTOIN FPIA CONTROLS

    K Number: K871567 · Decision Jul 1, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    82
    Applicant Total
    164
    Review Days
    70

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    Basic Information

    Device Name
    PHENYTOIN FPIA CONTROLS
    K Number
    K871567
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    April 22, 1987
    Decision Date
    July 1, 1987
    Product Code
    LAS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LAS Drug Specific Control Materials

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