BEUDAMED
    Product Code: JGX FDA class 1 21 CFR 862.1705

    Turbidimetric Method, Triglycerides

    Clinical Chemistry

    Turbidimetric Method for Triglycerides is a clinical chemistry test system that measures serum triglyceride levels by detecting turbidity formed when triglycerides interact with reagents, used in lipid panel testing and cardiovascular risk assessment. It is classified as FDA Class 1 (lowest risk), governed solely by general controls. The product code is JGX, regulated under 21 CFR 862.1705, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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

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    Basic Information

    Product Code
    JGX
    Device Class
    FDA class 1
    Regulation Number
    862.1705
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    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
    K831874 LIPASE REAGENT SET