BEUDAMED
    Product Code: LPW FDA class 1 21 CFR 862.1542

    System, Test, Oxalate

    Clinical Chemistry

    The Oxalate Test System is an in vitro diagnostic device used to measure oxalate concentration in biological specimens such as urine or plasma, primarily to investigate conditions such as hyperoxaluria and kidney stone formation. It is classified as a Class 1 (lowest risk) device, subject only to general controls, and is the least burdensome regulatory category, generally exempt from premarket notification. The product code is LPW, regulated under 21 CFR 862.1542, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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

    Basic Information

    Product Code
    LPW
    Device Class
    FDA class 1
    Regulation Number
    862.1542
    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
    K883525 OXALATE REAGENT

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.