BEUDAMED
    Product Code: GGH FDA class 1 21 CFR 864.1850

    Iron Stains

    Hematology

    Iron Stains (product code GGH) are histochemical staining reagents used in hematology and pathology laboratories to detect iron deposits in tissue sections or bone marrow smears, aiding in the diagnosis of iron storage disorders and assessment of iron stores. This device is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.1850 in the Hematology specialty (HE), this device is GMP exempt.

    View on FDA
    510(k)s
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GGH
    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
    K884011 SNAP N' STAIN IRON STAIN

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.