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510(k) Data Aggregation

    K Number
    K050014
    Device Name
    HEMONIR TM
    Manufacturer
    NIR DIAGNOSTICS, INC.
    Date Cleared
    2005-05-05

    (122 days)

    Product Code
    GLY, JKS
    Regulation Number
    864.7500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIR DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemoNIR is intended for in vitro diagnostic use by healthcare professionals in quantitative testing of whole blood for total hemoglobin, methernoglobin and carboxyhemoglobin.
    Device Description
    HemoNIR is a small, portable, battery-powered system using rechargeable batteries to measure total hemoglobin, methemoglobin and carboxyhemoglobin using spectroscopic technology. The system uses inexpensive disposable sample tabs and requires no sample preparation or reagents. Samples are introduced into the HemoNIR, JM by using sample tabs. The sample tab well is filled with approximately 10uL of sample and is then inserted into the sample slot of the HemoNIR, "10 unit. The unit automatically starts-up and runs its built-in self-test before performing the measurements. After less than 30 seconds from sample insertion, results will be displayed on the built-in LCD.
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