BEUDAMED
    Product Code: JKF FDA class 1 21 CFR 862.1380

    Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge

    Clinical Chemistry

    This device is a colorimetric clinical chemistry reagent system using the dinitrophenyl hydrazone reaction to measure hydroxybutyric dehydrogenase (HBD) activity in patient specimens, an enzyme associated with myocardial and hepatic injury when elevated in serum. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls without a premarket notification. The product code is JKF, regulated under 21 CFR 862.1380, and assigned to the Clinical Chemistry medical specialty.

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    510(k)s
    2
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    2
    Years Active
    2

    Basic Information

    Product Code
    JKF
    Device Class
    FDA class 1
    Regulation Number
    862.1380
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K861855 HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
    K834084 HYDROXYBUTYRATE DEHYDROGENASE REAGENT

    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.