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510(k) Data Aggregation

    K Number
    K060850
    Device Name
    NOD CHEMISTRY CONTROL
    Manufacturer
    BIORESOURCE TECHNOLOGY, INC.
    Date Cleared
    2006-05-30

    (63 days)

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

    BIORESOURCE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NOD™ Chemistry Control is a two-level control set that is intended for in-vitro diagnostic use to monitor the precision of laboratory testing procedures for the analytes listed in the package insert (routine chemistries).
    Device Description
    The NOD™ Chemistry Control is a two-level control set.
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    K Number
    K040352
    Device Name
    NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)
    Manufacturer
    BIORESOURCE TECHNOLOGY, INC.
    Date Cleared
    2004-04-02

    (50 days)

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

    BIORESOURCE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NOVA-ONE Control is intended for use in the laboratory to monitor the accuracy and rrovit one of the listed constituents. The routine use of quality control materials is an integral part of evaluating the accuracy and precision of laboratory analysis.
    Device Description
    NOVA-ONE Lipid Control Human Liquid Lipid Control
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    K Number
    K023032
    Device Name
    LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
    Manufacturer
    BIORESOURCE TECHNOLOGY, INC.
    Date Cleared
    2002-10-08

    (27 days)

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

    BIORESOURCE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquid Human Glycosylated Hemoglobin (A1C) Control is intended for use in the laboratory to monitor the precission and accuracy of Glycosylated Hemoglobin (A1C) assay procedures for the methods listed in the package insert. The routine use of quality control materials is an integral part of ensuring the accuracy and precision of laboratory analyses.
    Device Description
    Not Found
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