BEUDAMED
    Product Code: JFO FDA class 2 21 CFR 862.1145

    Fluorometric, Calcium

    Clinical Chemistry

    Fluorometric Calcium measurement is a clinical chemistry test system that uses fluorescence-based methods to quantify calcium concentration in biological specimens, aiding in the evaluation of calcium metabolism disorders and related conditions. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JFO, regulated under 21 CFR 862.1145, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    JFO
    Device Class
    FDA class 2
    Regulation Number
    862.1145
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    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
    K920974 BACTIDROP ACRIDINE ORANGE

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.