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510(k) Data Aggregation

    K Number
    K992846
    Device Name
    HICHEM TOTAL PROTEIN REAGENT
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    1999-10-18

    (55 days)

    Product Code
    CEK
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    CEK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. Total protein results are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This reagent is intended for professional use only.
    Device Description
    HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems.
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    K Number
    K973108
    Device Name
    TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1998-03-02

    (195 days)

    Product Code
    CEK
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    CEK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of Total Protein in urine and cerebrospinal fluid (CSF). For IN VITRO diagnostic use.
    Device Description
    Total Protein (Micro) Assay
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    K Number
    K980042
    Device Name
    CARESIDE TOTAL PROTEIN
    Manufacturer
    EXIGENT DIAGNOSTICS, INC.
    Date Cleared
    1998-02-04

    (29 days)

    Product Code
    CEK
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    CEK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use with Exigent Diagnostics CareSide™ Analyzer to measure total protein from whole blood, heparinized plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
    Device Description
    CareSide™ Total Protein cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure total protein concentration in whole blood, plasma or serum specimens. The CareSide™ Total Protein cartridge, a single use disposable in vitro diagnostic test carridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of total protein concentration. The film cartridge (patent pending) contains all reagents necessary to measure total protein concentration. When used in conjunction with the CareSide™ Albumin cartidge on the CareSide™ Analyzer, the analyzer calculates globulin (as the difference between the total protein and albumin concentrations) and the albumin/globulin ratio (A/G ratio).
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    K Number
    K971524
    Device Name
    TOTAL PROTEIN OR TP
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-05-16

    (18 days)

    Product Code
    CEK
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    CEK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961864
    Device Name
    CSF/URINE TOTAL PROTEIN
    Manufacturer
    TECO DIAGNOSTICS
    Date Cleared
    1996-10-24

    (163 days)

    Product Code
    CEK
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    CEK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955905
    Device Name
    STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
    Manufacturer
    SOLARCARE TECHNOLOGIES CORP,INC.
    Date Cleared
    1996-05-30

    (153 days)

    Product Code
    CEK
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    CEK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955936
    Device Name
    TOTAL PROTEIN REAGENT
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1996-03-12

    (82 days)

    Product Code
    CEK
    Regulation Number
    862.1635
    Why did this record match?
    Product Code :

    CEK

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

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