BEUDAMED
    Product Code: IAW FDA class 1 21 CFR 864.4010

    Collodion

    Pathology

    Collodion is a nitrocellulose solution used in histology as an embedding medium for tissue sections, particularly useful for large or delicate specimens, and also used to coat glass slides and to attach sections during staining procedures. 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 IAW, regulated under 21 CFR 864.4010, in the Pathology medical specialty. This device is exempt from GMP 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
    IAW
    Device Class
    FDA class 1
    Regulation Number
    864.4010
    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.