BEUDAMED
    Product Code: LDY FDA class 1 21 CFR 864.4010

    Fixative, Formalin-Containing

    Pathology

    A formalin-containing fixative is a widely used pathology reagent in which formaldehyde in aqueous solution preserves biological tissue specimens by cross-linking proteins, maintaining tissue architecture for histological examination and diagnostic interpretation. It is classified as FDA Class 1, subject only to general controls, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is LDY, regulated under 21 CFR 864.4010, in the Pathology specialty. No premarket notification is required.

    View on FDA
    510(k)s
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    LDY
    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
    K880549 DIACYTE FIXATIVE SOLUTION

    FEI Numbers

    This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.