BEUDAMED
    Product Code: DJN FDA class 2 21 CFR 862.3150

    Mercury Dithiazone, Colorimetry, Barbiturate

    Clinical Toxicology

    The Mercury Dithiazone Colorimetric Barbiturate test uses colorimetric reaction with mercury dithiazone to detect and quantify barbiturate compounds in biological specimens, supporting emergency toxicology and clinical drug monitoring applications. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3150 within the Clinical Toxicology specialty. This 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
    —

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    Basic Information

    Product Code
    DJN
    Device Class
    FDA class 2
    Regulation Number
    862.3150
    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
    K823237 BARBITURATE TEST SET #0550-050