BEUDAMED
    Product Code: LDZ FDA class 1 21 CFR 864.4010

    Fixative, Alcohol Containing

    Pathology

    An alcohol-containing fixative is a pathology reagent that uses ethanol or other alcohols to dehydrate and preserve tissue specimens, commonly used as an alternative or adjunct to formalin fixation in histology and cytology laboratories. It is classified as FDA Class 1, the lowest risk category, and is exempt from GMP requirements. The product code is LDZ, regulated under 21 CFR 864.4010, in the Pathology specialty. No premarket notification is required.

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    510(k)s
    8
    FEI Numbers
    43
    Registration Numbers
    43
    Unique Applicants
    7
    Years Active
    11

    Basic Information

    Product Code
    LDZ
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K883048 ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION
    K881922 CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE
    K881698 ATS PVA FIXATIVE SOLUTION
    K862725 SACCOMANNO SPECIMAN SOLUTION
    K843428 BIOFIX
    K842913 WRIGHT STAIN FIXATIVE
    K831061 PVA FIXATIVE/FORMALIN
    K761138 FA TISSUE FIXATIVE & WASH SET

    FEI Numbers

    This FDA classification entry is associated with 43 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.