BEUDAMED
    Product Code: IGB FDA class 1 21 CFR 864.4010

    Solution, Formalin-Sodium Acetate

    Pathology

    Formalin-Sodium Acetate Solution is a tissue fixative used in pathology laboratories to preserve biological specimens prior to histological processing and microscopic analysis. The addition of sodium acetate buffers the formalin to reduce tissue shrinkage and improve morphological preservation. 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 IGB, 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.

    View on FDA
    510(k)s
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    IGB
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K803054 SAF FIXATIVE

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.