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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?
    Product Code :

    GLY

    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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    K Number
    K993104
    Device Name
    STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Date Cleared
    1999-12-02

    (77 days)

    Product Code
    GLY
    Regulation Number
    864.7500
    Why did this record match?
    Product Code :

    GLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stat Profile pHOx CO-Oximeter Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of oxyhemoglobin, carboxyhemoglobin, methemoglobin, and deoxyhemoglobin in human blood.
    Device Description
    Not Found
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    K Number
    K955013
    Device Name
    NOVA CO-OXIMETER ANALYZER
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Date Cleared
    1996-04-25

    (176 days)

    Product Code
    GLY
    Regulation Number
    864.7500
    Why did this record match?
    Product Code :

    GLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K952725
    Device Name
    MULTICHECK
    Manufacturer
    RADIOMETER AMERICA, INC.
    Date Cleared
    1996-02-20

    (251 days)

    Product Code
    GLY
    Regulation Number
    864.7500
    Why did this record match?
    Product Code :

    GLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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