BEUDAMED
    Product Code: KSL FDA class 1 21 CFR 864.9320

    Solution, Copper Sulfate For Specific Gravity Determinations

    Hematology

    This device is a copper sulfate solution used in blood banking to perform specific gravity-based screening of blood donors, providing a rapid, non-instrumental method to estimate hemoglobin concentration and screen for anemia before donation. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is KSL, regulated under 21 CFR 864.9320 within the Hematology specialty. No special flags apply.

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    510(k)s
    2
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    2
    Years Active
    7

    Basic Information

    Product Code
    KSL
    Device Class
    FDA class 1
    Regulation Number
    864.9320
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K882101 HEMOGLOBIN SCREENING DEVICE
    K803095 COPPER SULFATE SOLUTION SP. GR.1.055

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.