BEUDAMED
    Product Code: GKX FDA class 2 21 CFR 864.5200

    Instrument, Automated Platelet Counting

    Hematology

    Instrument, Automated Platelet Counting (product code GKX) is an automated hematology analyzer used to enumerate platelets in whole blood samples using electrical impedance or optical detection methods, providing platelet counts essential for the diagnosis and monitoring of thrombocytopenia, thrombocytosis, and bleeding disorders. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.5200 in the Hematology specialty (HE), it is eligible for third-party review.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    18

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    Basic Information

    Product Code
    GKX
    Device Class
    FDA class 2
    Regulation Number
    864.5200
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K014203 ABX MICROS 60 HEMATOLOGY ANALYZER
    K840948 CLEAR POROUS PLASTIC-HYPOALLERGENIC