BEUDAMED
    Product Code: MLL FDA class 2 21 CFR 864.7415

    Hemoglobin C (Abnormal Hemoglobin Variant)

    Hematology

    The Hemoglobin C (Abnormal Hemoglobin Variant) assay is an in vitro diagnostic test used to detect and identify hemoglobin C, an abnormal hemoglobin variant caused by a point mutation in the beta-globin gene, in patient blood samples to diagnose hemoglobin C trait or disease, which can cause mild hemolytic anemia. Classified as a Class 2 device under 21 CFR 864.7415 within the Hematology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

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

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    Basic Information

    Product Code
    MLL
    Device Class
    FDA class 2
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Review Panel
    HE
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K923153 HEMOCARD, HEMOGLOBIN C ASSAY

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.