BEUDAMED
    Product Code: LDX FDA class 1 21 CFR 864.4010

    Fixative, Metallic Containing

    Pathology

    A metallic-containing fixative is a pathology laboratory reagent that uses heavy metal salts to preserve and fix tissue specimens for histological examination, providing good cellular detail and tissue morphology for microscopic diagnosis. It is classified as FDA Class 1 and is exempt from GMP requirements, indicating very low risk. The product code is LDX, regulated under 21 CFR 864.4010, in the Pathology specialty. No premarket notification is required.

    View on FDA
    510(k)s
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    1
    Years Active
    —

    Research product code LDX in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    LDX
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K882874 ZINC FORMALIN

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.