BEUDAMED
    Product Code: DMR FDA class 1 21 CFR 862.3240

    Solution, M-Nitrophenol, Specific Reagent For Cholinesterase

    Clinical Toxicology

    The Solution, M-Nitrophenol, as a Specific Reagent for Cholinesterase is a laboratory reagent used in colorimetric assays to measure cholinesterase activity in patient specimens, which is relevant to assessing organophosphate or carbamate pesticide poisoning. It is a Class 1 device subject to general controls only and does not require premarket notification. The product code is DMR, regulated under 21 CFR 862.3240, within the Clinical Toxicology specialty. No special regulatory flags apply.

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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
    DMR
    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
    K790986 RF CONTROLS