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510(k) Data Aggregation

    K Number
    K022690
    Device Name
    PAROS CRP
    Manufacturer
    Date Cleared
    2002-12-23

    (132 days)

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

    HORIBA LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indications for use of the Paros CRP are for aiding in diagnosis and monitoring of inflammatory diseases. The primary utility is for screening for the presence of inflammatory disease, by measuring CRP on anti-coagulated whole blood samples, and thus eliminating the requirement for sample centrifugation. CRP measurement on serum samples is also possible. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein, aids in evaluation of the amount of inflammatory injury to body tissues.
    Device Description
    The Paros CRP is a benchtop C-Reactive Protein Immunological Test System. It is a single parameter instrument (CRP only), with the ability to measure CRP on Whole Blood and Serum samples in-vitro. It employs the same measurement principles as the CRP measurement module of the ABX / Horiba ™MICROS CRP (K002646, October 2000). The Paros CRP does not have a cell counting module. The CRP levels are measured in patients by reacting anti-CRP antibody coated latex particles with lyzed blood, and determining the rate of the turbidimetric reaction in the near infrared spectrum.
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