BEUDAMED
    Product Code: IAM FDA class 1 21 CFR 864.4010

    Solution, Lugol'S

    Pathology

    Lugol's Solution is an iodine-potassium iodide solution used in pathology and histology to detect glycogen and starch in tissue sections, and in clinical settings for gynecological colposcopy to identify abnormal epithelial tissue. 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 IAM, 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
    16
    Registration Numbers
    16
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    IAM
    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 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.