BEUDAMED
    Product Code: LAZ FDA class 1 21 CFR 862.3280

    N-Acetylprocainamide Control Materials

    Clinical Toxicology

    N-acetylprocainamide control materials are quality control preparations used in clinical toxicology laboratories to validate assay systems measuring N-acetylprocainamide, the principal active metabolite of the antiarrhythmic drug procainamide. The device is FDA Class 1, the lowest risk category, requiring only general controls with no premarket notification. The product code is LAZ, regulated under 21 CFR 862.3280, in the Clinical Toxicology specialty. No special risk flags apply.

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    510(k)s
    4
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    3
    Years Active
    40

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    Basic Information

    Product Code
    LAZ
    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 4 510(k) clearances via K numbers.

    K Number Device Name
    K211667 Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
    K851474 VYGON SPINAL ANESTHESIA TRAY CODE NO. 190
    K823127 ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL
    K811461 EMIT-AND METHOTREXATE CONTROL