BEUDAMED
    Product Code: LAX FDA class 1 21 CFR 862.3280

    Lidocaine Control Materials

    Clinical Toxicology

    Lidocaine control materials are quality control reference preparations used in clinical toxicology laboratories to assess the performance of assay systems measuring lidocaine, a local anesthetic and antiarrhythmic drug. FDA Class 1 classification applies, reflecting low risk and the absence of a premarket notification requirement. The product code is LAX, regulated under 21 CFR 862.3280, in the Clinical Toxicology specialty. No special risk flags are noted.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    LAX
    Device Class
    FDA class 1
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    4

    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
    K823865 ADVANCE SYS. EMIT-CAD LIDOCAINE CONTROL