BEUDAMED
    Product Code: DCJ FDA class 1 21 CFR 866.5160

    Beta-Globulin, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting beta-globulin, the plasma protein fraction that includes transferrin, complement proteins, and certain clotting factors, including antigen, antiserum, and control components for clinical laboratory immunoassay applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. The product code is DCJ, regulated under 21 CFR 866.5160, within the Immunology 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
    DCJ
    Device Class
    FDA class 1
    Regulation Number
    866.5160
    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
    K891093 ACA (R) DIGITOXIN CALIBRATOR