BEUDAMED
    Product Code: KQH FDA class 2 21 CFR 864.5300

    Red-Cell Indices

    Hematology

    This device involves red cell indices testing, used in hematology analyzers or assay systems to measure mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), which aid in the classification and diagnosis of anemia. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KQH, regulated under 21 CFR 864.5300 within the Hematology specialty. This device is eligible for third-party review.

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

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    Basic Information

    Product Code
    KQH
    Device Class
    FDA class 2
    Regulation Number
    864.5300
    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
    K862089 V-MARC 88A COMPUTER