BEUDAMED
    Product Code: KZY FDA class 2 21 CFR 862.3150

    High Pressure Liquid Chromatography, Barbiturate

    Clinical Toxicology

    High pressure liquid chromatography for barbiturate detection is an analytical method used in clinical toxicology to measure barbiturate drug levels in patient specimens for monitoring or overdose assessment. The device is classified as FDA Class 2, signifying moderate risk and the need for 510(k) premarket notification. The product code is KZY, regulated under 21 CFR 862.3150, in the Clinical Toxicology specialty. It is eligible for third-party review under the FDA's accredited reviewer program.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KZY
    Device Class
    FDA class 2
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
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    Summary Malfunction Reporting