BEUDAMED
    Product Code: IFH FDA class 1 21 CFR 864.4010

    Solution, Zenker'S

    Pathology

    Zenker's Solution is a mercuric chloride-based fixative used in histopathology to preserve tissue specimens for routine histological examination, producing excellent nuclear and cytoplasmic detail and particularly well-suited for preservation of liver, spleen, and hematopoietic tissue. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is IFH, regulated under 21 CFR 864.4010, in the Pathology medical specialty. This device is exempt from GMP requirements.

    View on FDA
    510(k)s
    2
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    2
    Years Active
    2

    Basic Information

    Product Code
    IFH
    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
    K842732 ZENKERS SOLUTION
    K822127 VOLU-SOL ZENKERS FIXATIVE

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.