BEUDAMED
    Product Code: HYG FDA class 1 21 CFR 864.1850

    Glenner'S Stain

    Hematology

    Glenner's stain is a histochemical staining preparation used in pathology to selectively stain specific tissue components or cellular structures, typically used in specialized diagnostic protocols in surgical pathology or hematopathology. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYG falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HYG
    Device Class
    FDA class 1
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    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
    K802690 ULTRAPAK CAT. #100-0251