BEUDAMED
    Product Code: LEW FDA class 2 21 CFR 862.3880

    Thin Layer Chromatography, Theophylline

    Clinical Toxicology

    The Thin Layer Chromatography test for Theophylline is a laboratory method used to separate and identify theophylline in biological specimens for therapeutic drug monitoring purposes, primarily in patients receiving theophylline for respiratory conditions. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LEW and falls under 21 CFR 862.3880 in the Clinical Toxicology specialty. This device is eligible for third-party 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
    LEW
    Device Class
    FDA class 2
    Regulation Number
    862.3880
    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
    K771120 IMPREFLEX ALGINATE IMPRESSION MATERIAL