BEUDAMED
    Product Code: KDZ FDA class 1 21 CFR 864.3010

    Device, Decalcifier, Electrolytic

    Pathology

    An electrolytic decalcifier device is a laboratory instrument that uses electrical current to accelerate the removal of calcium from fixed bone or calcified tissue specimens, speeding up the preparation process for histopathological sectioning and analysis. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls. Product code KDZ is regulated under 21 CFR 864.3010 in the Pathology medical specialty. This device is GMP exempt, meaning it is not subject to full Quality System Regulation requirements.

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    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KDZ
    Device Class
    FDA class 1
    Regulation Number
    864.3010
    Medical Specialty
    Pathology
    Review Panel
    PA
    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 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.