BEUDAMED
    Product Code: KZB FDA class 1 21 CFR 866.2170

    Automated Colony Counter

    Microbiology

    The Automated Colony Counter is a laboratory instrument that uses optical or image-analysis technology to automatically enumerate microbial colonies grown on culture media plates, replacing manual counting in clinical microbiology workflows to improve speed and reproducibility. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KZB, regulated under 21 CFR 866.2170, in the Microbiology medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KZB
    Device Class
    FDA class 1
    Regulation Number
    866.2170
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    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
    K893519 TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.