BEUDAMED
    Product Code: IFY FDA class 1 21 CFR 864.4010

    Gelatin-Formalin

    Pathology

    Gelatin-Formalin is a tissue processing reagent used in pathology laboratories as a combined fixative and adhesive to preserve and affix tissue sections to microscopy slides. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IFY, regulated under 21 CFR 864.4010, within the Pathology medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.

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

    Product Code
    IFY
    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
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    Summary Malfunction Reporting