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

    PHENYTOIN FPIA REAGENT SET AND CALIBRATORS

    K Number: K943313 · Decision Oct 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    164
    Review Days
    108

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    Basic Information

    Device Name
    PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
    K Number
    K943313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    July 11, 1994
    Decision Date
    October 27, 1994
    Product Code
    LGR
    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
    LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

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