BEUDAMED
    Product Code: LBA FDA class 1 21 CFR 862.3280

    Procainamide Control Materials

    Clinical Toxicology

    Procainamide control materials are reference materials used in clinical toxicology to ensure the accuracy of assay systems that measure serum levels of procainamide, an antiarrhythmic agent requiring therapeutic drug monitoring. Classified as FDA Class 1, they are subject only to general controls and do not require premarket notification. The product code is LBA, regulated under 21 CFR 862.3280, in the Clinical Toxicology specialty. No special flags apply.

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

    Basic Information

    Product Code
    LBA
    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
    K833227 SONICAID MODEL D206E AIR EMBOLI-DETECT