BEUDAMED
    Product Code: IGE FDA class 1 21 CFR 864.4010

    Solution, Formalin Ammonium Bromide

    Pathology

    Formalin Ammonium Bromide Solution is a specialized tissue fixative used in pathology laboratories, with the ammonium bromide component aiding in the preservation and visualization of certain tissue structures and cellular components during histological staining. 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 IGE, 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
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    11

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    Basic Information

    Product Code
    IGE
    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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K950560 SALINE SOLUTINE, STERILE
    K842862 CB FORMALIN