BEUDAMED
    Product Code: DIR FDA class 2 21 CFR 862.3250

    Free Radical Assay, Cocaine

    Clinical Toxicology

    The Free Radical Assay for Cocaine is a laboratory method that uses free radical chemistry to detect and quantify cocaine in biological specimens, supporting forensic and clinical toxicology investigations. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3250 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
    —

    Basic Information

    Product Code
    DIR
    Device Class
    FDA class 2
    Regulation Number
    862.3250
    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
    K863888 DU PONT PHENYTOIN ASSAY AND CALIBRATOR