BEUDAMED
    Product Code: DJH FDA class 2 21 CFR 862.3660

    Gas Chromatography, Phenobarbital

    Clinical Toxicology

    The Gas Chromatography Phenobarbital test is a laboratory assay that uses gas chromatographic separation to detect and quantify phenobarbital in patient blood specimens, supporting therapeutic drug monitoring in patients being treated for epilepsy or other seizure disorders. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3660 within the Clinical Toxicology specialty. The device qualifies for third-party 510(k) review.

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

    Basic Information

    Product Code
    DJH
    Device Class
    FDA class 2
    Regulation Number
    862.3660
    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
    K843440 MINGO LOG 7