BEUDAMED
    Product Code: GJL FDA class 1 21 CFR 864.1850

    Romanowsky Stains

    Hematology

    Romanowsky Stains (product code GJL) are a class of polychromatic hematology stains that include Wright's stain, Giemsa stain, and related formulations, widely used to stain blood films and bone marrow smears for the morphological examination and differential classification of blood cells. This device is classified as FDA Class 1, the lowest risk category, 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.

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    510(k)s
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GJL
    Device Class
    FDA class 1
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Review Panel
    HE
    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
    K880544 WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.