BEUDAMED
    Product Code: LAC FDA class 2 21 CFR 862.3250

    High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites

    Clinical Toxicology

    High pressure liquid chromatography for cocaine and cocaine metabolites is a laboratory analytical method used in clinical toxicology to detect and quantify cocaine and its breakdown products in biological specimens. The device is FDA Class 2, meaning it requires 510(k) premarket clearance to demonstrate moderate-risk controls are in place. The product code is LAC, regulated under 21 CFR 862.3250, within the Clinical Toxicology specialty. It qualifies for third-party review.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    LAC
    Device Class
    FDA class 2
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
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    Summary Malfunction Reporting