BEUDAMED
    Product Code: JGT FDA class 2 21 CFR 862.1665

    Flame Photometry, Sodium

    Clinical Chemistry

    Flame Photometry for Sodium is a clinical chemistry test system that uses the characteristic emission spectrum of sodium in a flame to quantify sodium concentration in blood or urine, supporting diagnosis and management of electrolyte imbalances. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is JGT, regulated under 21 CFR 862.1665, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    8
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    8
    Years Active
    13

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    Basic Information

    Product Code
    JGT
    Device Class
    FDA class 2
    Regulation Number
    862.1665
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K896829 TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)
    K891574 LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030
    K841610 COMPONENTS FOR POTASSIUM, SODIUM CHLO
    K840216 SODIUM/POTASSIUM REAGENT SYS
    K834248 PARALLEL FLAME PHOTOMETER & SODIUM
    K811886 CESIUM DILUENT 7.5M
    K801892 KLINAR REAGENT PAK, #36010
    K770774 LYTETEK SYSTEM