BEUDAMED
    Product Code: LAE FDA class 2 21 CFR 862.3270

    High Pressure Liquid Chromatography, Codeine

    Clinical Toxicology

    High pressure liquid chromatography for codeine measurement is a laboratory system used to detect and quantify codeine in biological specimens as part of clinical toxicology or drug monitoring workflows. FDA Class 2 classification applies, requiring a 510(k) premarket submission. The product code is LAE, regulated under 21 CFR 862.3270, in the Clinical Toxicology specialty. The device is eligible for third-party review.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    2

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    Basic Information

    Product Code
    LAE
    Device Class
    FDA class 2
    Regulation Number
    862.3270
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K851480 VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW
    K832590 MOUTH-TO-MOUTH SHIELD APPLICATOR