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510(k) Data Aggregation

    K Number
    K955719
    Device Name
    SICKLE-2000
    Manufacturer
    MEDICUS TECHNOLOGIES, INC.
    Date Cleared
    1996-08-14

    (240 days)

    Product Code
    GIQ
    Regulation Number
    864.7415
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICUS TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SICKLE-2000 is an in-vitro centrifugal solubility test that detects Hemoglobin S, the abnormal hemoglobin found in sickle cell disease and sickle cell trait.
    Device Description
    SICKLE-2000 is an in-vitro centrifugal solubility test that detects Hemoglobin S, the abnormal hemoglobin found in sickle cell disease and sickle cell trait.
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