BEUDAMED
    Product Code: KIQ FDA class 1 21 CFR 864.2260

    Kit, Culture, Chromosome

    Hematology

    Chromosome Culture Kit is a laboratory device providing the reagents and materials necessary to culture cells and prepare chromosomal spreads for karyotyping and cytogenetic analysis, used in the diagnosis of chromosomal abnormalities, genetic disorders, and hematological malignancies. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIQ, regulated under 21 CFR 864.2260, within the Hematology medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KIQ
    Device Class
    FDA class 1
    Regulation Number
    864.2260
    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
    K790239 PHYTOHAEMAGGLUTININ

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.