BEUDAMED
    Product Code: DJQ FDA class 2 21 CFR 862.3670

    Test Reagents For Phenothiazine

    Clinical Toxicology

    The Test Reagents for Phenothiazine are laboratory reagents used to detect and identify phenothiazine compounds, a class of antipsychotic drugs, in biological specimens through colorimetric or other chemical reactions, supporting clinical toxicology and therapeutic drug monitoring. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3670 within the Clinical Toxicology specialty. The device is eligible 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
    DJQ
    Device Class
    FDA class 2
    Regulation Number
    862.3670
    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
    K894657 POLYSTAN HEART-LUNG MACHINE SYSTEM