BEUDAMED
    Product Code: JLL FDA class 1 21 CFR 862.1320

    Tubeless Analysis, Gastric Acidity

    Clinical Chemistry

    This device is a tubeless analysis system used to assess gastric acidity without direct intubation, typically by measuring the urinary excretion of a pH-sensitive indicator substance administered orally, used to evaluate gastric acid secretory function in a non-invasive manner. It is classified as FDA Class 1, subject only to general controls with no premarket submission required. The product code is JLL, regulated under 21 CFR 862.1320, within the Clinical Chemistry medical specialty.

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    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    JLL
    Device Class
    FDA class 1
    Regulation Number
    862.1320
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.