BEUDAMED
    Product Code: IDZ FDA class 1 21 CFR 864.3010

    Cassettes, Tissue

    Pathology

    Tissue cassettes are small perforated containers used in histopathology to hold tissue specimens during fixation, dehydration, and paraffin processing, and then serve as the base for embedding the specimen in paraffin for microtome sectioning. 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 IDZ, regulated under 21 CFR 864.3010, in the Pathology medical specialty. This device is exempt from GMP requirements.

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    510(k)s
    5
    FEI Numbers
    55
    Registration Numbers
    55
    Unique Applicants
    4
    Years Active
    10

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    Basic Information

    Product Code
    IDZ
    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 5 510(k) clearances via K numbers.

    K Number Device Name
    K863483 CASSETTE EMBOSSEER
    K862457 LYNX EL MICROSCOPY TISSUE PROCESSOR
    K833857 MACLEAN-FOGG, TISSUE CASSETTES
    K831334 TISSUE CASSETTES FOR PROCESSING-EM BED
    K760623 LANCER PARAPLAST HISTO PROCESS CASSETTE

    FEI Numbers

    This FDA classification entry is associated with 55 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.