BEUDAMED
    Product Code: JBY FDA class 2 21 CFR 864.6675

    Aggregometer, Platelet, Photo-Optical Scanning

    Hematology

    A photo-optical scanning platelet aggregometer uses light transmission or turbidimetry to continuously monitor changes in platelet suspension clarity during aggregation reactions triggered by agonists, providing a detailed assessment of platelet function for diagnosis of bleeding disorders. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JBY, regulated under 21 CFR 864.6675, within the Hematology medical specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    14

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    Basic Information

    Product Code
    JBY
    Device Class
    FDA class 2
    Regulation Number
    864.6675
    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
    K912201 PACKS-4 (TM) ANALYZER
    K771198 LUMI-AGGREGOMETER