BEUDAMED
    Product Code: DJE FDA class 2 21 CFR 862.3830

    Thin Layer Chromatography, Salicylate

    Clinical Toxicology

    The Thin Layer Chromatography Salicylate test uses thin layer chromatographic methods to detect and identify salicylate compounds, including aspirin metabolites, in biological specimens for therapeutic monitoring or toxicology investigations. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3830 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
    —

    Basic Information

    Product Code
    DJE
    Device Class
    FDA class 2
    Regulation Number
    862.3830
    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
    K802615 EMIT-STM OPIATE ASSAY