BEUDAMED
    Product Code: DIG FDA class 1 21 CFR 862.3240

    Cholinesterase Test Paper

    Clinical Toxicology

    The Cholinesterase Test Paper is a simple colorimetric test device used to measure cholinesterase enzyme activity in biological specimens, which can be depressed by exposure to organophosphate or carbamate pesticides, supporting occupational and clinical toxicology evaluations. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 862.3240 within the Clinical Toxicology specialty.

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

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    Basic Information

    Product Code
    DIG
    Device Class
    FDA class 1
    Regulation Number
    862.3240
    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
    K024339 COZART EIA OPIATES ORAL FLUID KIT

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.