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510(k) Data Aggregation

    K Number
    K062981
    Device Name
    I-CHROMA CRP TEST
    Date Cleared
    2007-07-13

    (287 days)

    Product Code
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    BODITECH DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The i-CHROMA™ CRP test along with i-CHROMA™ Reader is an in vitro diagnostic fluorescence immunoassay that measures C-Reactive Protein in whole blood and serum. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues, infection, and inflammatory disorders.
    Device Description
    Not Found
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