BEUDAMED
    Product Code: KQE FDA class 2 21 CFR 864.7360

    Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase

    Hematology

    This device is an erythrocytic glucose-6-phosphate dehydrogenase (G6PD) assay, an in vitro diagnostic test used to measure G6PD enzyme activity in red blood cells, used for diagnosing G6PD deficiency and assessing hemolytic anemia risk. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KQE, regulated under 21 CFR 864.7360 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
    —

    Research product code KQE in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    KQE
    Device Class
    FDA class 2
    Regulation Number
    864.7360
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K823900 GLUCOSE-6-PHOSPHATE DEHYDROGENASE