BEUDAMED
    Product Code: MPG FDA class 1 21 CFR 862.1505

    Urinary Carbohydrate Analysis Kit

    Clinical Chemistry

    The Urinary Carbohydrate Analysis Kit is a clinical chemistry in vitro diagnostic device used to detect and analyze carbohydrates (sugars) in urine samples, supporting the diagnosis of conditions such as galactosuria or other metabolic disorders. Classified as FDA Class 1 under 21 CFR 862.1505 in the Clinical Chemistry specialty, it is 510(k)-exempt and subject only to general controls. The product code is MPG.

    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
    MPG
    Device Class
    FDA class 1
    Regulation Number
    862.1505
    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
    K945519 FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM