BEUDAMED
    Product Code: KST FDA class 1 21 CFR 864.9125

    System, Blood Collection, Vacuum-Assisted, Manual

    Hematology

    This device is a manual vacuum-assisted blood collection system, such as an evacuated tube system with a holder and needle, used to draw venous blood samples from patients for laboratory testing. It is classified as FDA Class 1, indicating low risk, subject to general controls only. The product code is KST, regulated under 21 CFR 864.9125 within the Hematology specialty. No special flags apply.

    View on FDA
    510(k)s
    0
    FEI Numbers
    80
    Registration Numbers
    80
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    KST
    Device Class
    FDA class 1
    Regulation Number
    864.9125
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 80 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 80 registration numbers. Click on an entry to view related FDA registrations.