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510(k) Data Aggregation

    K Number
    K021636
    Device Name
    ALBUMIN REAGENT
    Manufacturer
    INTERSECT SYSTEMS, INC.
    Date Cleared
    2002-07-17

    (61 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERSECT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An albumin test system is an in vitro device intended to measure albumin concentration quantitatively in serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
    Device Description
    Not Found
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    K Number
    K011972
    Device Name
    DIRECT BILIRUBIN REAGENT
    Manufacturer
    INTERSECT SYSTEMS, INC.
    Date Cleared
    2001-08-27

    (63 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERSECT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for the quantitative determination of direct bilirubin in serum or plasma. Bilirubin is an organic compound formed during the catabolism of red blood cells and its measurement is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
    Device Description
    Not Found
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    K Number
    K011692
    Device Name
    HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
    Manufacturer
    INTERSECT SYSTEMS, INC.
    Date Cleared
    2001-07-25

    (55 days)

    Product Code
    LPS
    Regulation Number
    862.1377
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERSECT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
    Device Description
    Homogeneous Enzymic Homocysteine Reagent
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    K Number
    K003892
    Device Name
    TOTAL BILIRUBIN REAGENT
    Manufacturer
    INTERSECT SYSTEMS, INC.
    Date Cleared
    2001-02-20

    (64 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERSECT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983937
    Device Name
    DUAL VIAL CREATININE REAGENT
    Manufacturer
    INTERSECT SYSTEMS, INC.
    Date Cleared
    1999-01-06

    (62 days)

    Product Code
    CGX
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERSECT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A creatinine test system is an in vitro device intended to measure creatinine quantitatively in * serum, plasma or urine. Creatinine measurements are used in the diagnosis and treatment of certain renal functions.
    Device Description
    Dual Vial Creatinine Reagent
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    K Number
    K974833
    Device Name
    CK-NAC REAGENT
    Manufacturer
    INTERSECT SYSTEMS, INC.
    Date Cleared
    1998-02-13

    (51 days)

    Product Code
    CGS
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERSECT SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intersect CK Reagent is an in-vitro diagnostic product intended for use in the quantitative determination of creatine kinasc in human serum.
    Device Description
    Not Found
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