BEUDAMED
    Product Code: KHT FDA class 1 21 CFR 866.5370

    Fraction V, Antigen, Antiserum, Control

    Immunology

    Fraction V Antigen, Antiserum, Control is an immunological reagent set used in clinical immunology laboratories as a reference material for the detection and measurement of albumin (Fraction V) using antigen-antibody reactions, serving as quality control in immunodiffusion and immunoelectrophoresis assays. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KHT, regulated under 21 CFR 866.5370, within the Immunology medical specialty.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KHT
    Device Class
    FDA class 1
    Regulation Number
    866.5370
    Medical Specialty
    Immunology
    Review Panel
    IM
    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
    K822516 VIVONEX MASS GASTRASTOMY TUBE