BEUDAMED
    Product Code: IGD FDA class 1 21 CFR 864.4010

    Solution, Formol Calcium

    Pathology

    Formol Calcium Solution is a calcium-containing formalin fixative used in pathology laboratories, particularly for the preservation of lipid-rich tissues and specimens requiring retention of fatty components for histological analysis. 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 IGD, 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
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    IGD
    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

    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.