BEUDAMED
    Product Code: IDP FDA class 1 21 CFR 864.3010

    Microtome, Cryostat

    Pathology

    A cryostat microtome is a refrigerated cabinet-mounted instrument that cuts frozen tissue sections at sub-zero temperatures, enabling rapid preparation of fresh tissue for intraoperative diagnosis and for preserving labile antigens and lipids for immunohistochemistry. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is IDP, regulated under 21 CFR 864.3010, in the Pathology medical specialty. This device is exempt from GMP requirements.

    View on FDA
    510(k)s
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    IDP
    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

    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
    K883514 EXAKT CUTTING & GRINDING SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.