BEUDAMED
    Product Code: DMY FDA class 2 21 CFR 862.3640

    Gas Chromatography, Morphine

    Clinical Toxicology

    The Gas Chromatography system for Morphine is a laboratory analytical device that uses gas chromatographic techniques to detect and quantify morphine in patient biological specimens for toxicological analysis and therapeutic monitoring. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DMY, regulated under 21 CFR 862.3640, within the Clinical Toxicology specialty. It 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
    DMY
    Device Class
    FDA class 2
    Regulation Number
    862.3640
    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
    K990409 ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)