BEUDAMED
    Product Code: JLP FDA class 1 21 CFR 862.1605

    Spectrophotometric Method, Pregnanediol

    Clinical Chemistry

    This device is a spectrophotometric reagent system used in clinical chemistry to measure pregnanediol, a urinary metabolite of progesterone, in patient specimens, used in the monitoring of ovarian function, menstrual disorders, and pregnancy-related progesterone status. It is classified as FDA Class 1, subject only to general controls with no premarket notification required. The product code is JLP, regulated under 21 CFR 862.1605, within the Clinical Chemistry medical specialty.

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

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    Basic Information

    Product Code
    JLP
    Device Class
    FDA class 1
    Regulation Number
    862.1605
    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
    K872843 OVEIA (TM) DUAL ANALYTE

    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.