BEUDAMED
    Product Code: LAI FDA class 2 21 CFR 862.3650

    Thin Layer Chromatography, Opiates

    Clinical Toxicology

    Thin layer chromatography for opiate detection is an analytical method used in clinical toxicology to screen for opiates in biological samples using chromatographic separation on a coated plate. The device is FDA Class 2, requiring 510(k) premarket clearance to confirm substantial equivalence to a legally marketed predicate. The product code is LAI, regulated under 21 CFR 862.3650, in the Clinical Toxicology specialty. It qualifies 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
    LAI
    Device Class
    FDA class 2
    Regulation Number
    862.3650
    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
    K932209 TOXI*LAB LTD OPIATE SYSTEM