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510(k) Data Aggregation

    K Number
    K012243
    Device Name
    MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL
    Manufacturer
    Date Cleared
    2001-08-20

    (34 days)

    Product Code
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMATRONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MCC™ URICHECK™ from HEMATRONIX, INC. is a synthetic matrix based assayed liquid urine multi-constituent control intended to monitor the precision and accuracy of instrument used in the clinical laboratory environment. MCC™ URICHECK™ is intended to monitor the precision and accuracy of instrument used in the methods when run as a patient sample and is ready to use. Expected ranges for the chemical and physical properties of MCC™ URICHECK™ have been established for monitoring or quantitative "constituents" used in routine clinical chemistry analysis.
    Device Description
    MCC™ URICHECK™ Assayed Liquid Urine Multi-Constituent Control is a synthetic matrix based assayed liquid urine multi-constituent control.
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    K Number
    K993496
    Device Name
    RETIC-QUINOX
    Manufacturer
    Date Cleared
    1999-11-30

    (46 days)

    Product Code
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMATRONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Retic-Quinox is a whole blood reference control material designed to monitor the accuracy and precision of Coulter instruments equipped with reticulocye measuring capabilities using VCS technology.
    Device Description
    Retic-Quinox is a reference control material designed to monitor the accuracy and precision of Coulter instruments capable of performing reticulocyte counts.
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    K Number
    K972710
    Device Name
    QUANTIFY(901)
    Manufacturer
    Date Cleared
    1997-08-15

    (25 days)

    Product Code
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMATRONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hematronix qUAntify™ Control System is a liquid, ready-to-use, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals. Controls evaluate the quality of day-to-day test performance. The qUAntify Control System is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick testing. Alternative tests such as the Glucose (Clinites), Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified urine hCG tests. Two distinct levels are included to verify the recovery of normal and elevated patient values.
    Device Description
    The Hematronix qUAntify™ Control System is a liquid, ready-to-use, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals.
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    K Number
    K960471
    Device Name
    TRI-COUNT 20
    Manufacturer
    Date Cleared
    1996-03-20

    (48 days)

    Product Code
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMATRONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K960005
    Device Name
    TRI-COURT 20-T
    Manufacturer
    Date Cleared
    1996-03-19

    (77 days)

    Product Code
    Regulation Number
    864.8625
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMATRONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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