BEUDAMED
    Product Code: DOZ FDA class 2 21 CFR 862.3350

    Liquid Chromatography, Diphenylhydantoin

    Clinical Toxicology

    The Liquid Chromatography system for Diphenylhydantoin is a laboratory analytical device that uses liquid chromatographic techniques to detect and quantify diphenylhydantoin (phenytoin) in patient serum or plasma for therapeutic drug monitoring in patients receiving anticonvulsant therapy. It is a Class 2 device requiring a 510(k) premarket notification. The product code is DOZ, regulated under 21 CFR 862.3350, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    DOZ
    Device Class
    FDA class 2
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K781941 ANALYSIS SYSTEM, PREP SAMPLE