BEUDAMED
    Product Code: IFQ FDA class 1 21 CFR 864.4010

    Formulations, Mercuric Chloride For Tissue

    Pathology

    Mercuric Chloride Tissue Formulations are mercury-based fixative solutions used in histopathology to preserve tissue specimens, producing excellent preservation of cytoplasmic detail and nuclear morphology, typically used as a component of composite fixatives such as Zenker's, Helly's, and B5 fixatives. 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 IFQ, 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
    2
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    0

    Basic Information

    Product Code
    IFQ
    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
    K792714 PARA-PAK PVA
    K792654 CULTURETTE BRAND-PVA/FORMALIN KIT

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.