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510(k) Data Aggregation

    K Number
    K041051
    Device Name
    RAICHEM BUN RATE REAGENT (LIQUID)
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2004-06-30

    (72 days)

    Product Code
    CDQ
    Regulation Number
    862.1770
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMAGEN DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This reaqent is for the quantitative in vitro enzymatic determination of urea nitrogen in serum or plasma by measurement of the initial rate of reaction. This urea nitrogen test system is a device intended to measure urea nitrogen (an endproduct of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
    Device Description
    Urea Nitrogen (BUN) test system
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    K Number
    K041052
    Device Name
    RAICHEM GLUCOSE UV (LIQUID)
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2004-06-30

    (72 days)

    Product Code
    CFR
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMAGEN DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This reagent is intended for the quantitative enzymatic determination of glucose in serum or plasma. For in vitro diagnostic use only. This glucose test system is a device intended to measure glucose quantitatively in serum or plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell tumors.
    Device Description
    Glucose test system
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    K Number
    K041009
    Device Name
    RAICHEM CALCIUM (OCPC) LIQUID REAGENT
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2004-06-25

    (67 days)

    Product Code
    CIC
    Regulation Number
    862.1145
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMAGEN DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This reagent is intended for the quantitative determination of Calcium in serum, heparinized plasma, or urine. For in vitro diagnostic use only. This calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. The intended patient population may be adult, pediatric, and neonatal.
    Device Description
    Not Found
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    K Number
    K031101
    Device Name
    RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2003-06-16

    (70 days)

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

    HEMAGEN DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RAICHEM Assayed Control Serum is a general purpose chemistry control for use in monitoring the accuracy and precision of clinical chemistry assays.
    Device Description
    Not Found
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    K Number
    K023784
    Device Name
    RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2002-12-24

    (42 days)

    Product Code
    LBR
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMAGEN DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Raichem Cholesterol Rapid Liquid Reagent may be used with the CANTROL® HDL Cholesterol Precipitating Reagent Tubes to separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease. For In Vitro Diagnostic Use Only.
    Device Description
    Not Found
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    K Number
    K022772
    Device Name
    RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2002-09-17

    (27 days)

    Product Code
    MRR
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMAGEN DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This reagent is intended for the quantitative measurement of LDL Cholesterol (LDL-C) levels in serum or plasma samples. LDL-Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
    Device Description
    RAICHEM® LDL – Cholesterol Direct Reagent
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    K Number
    K022767
    Device Name
    RAICHEM LIPID CALIBRATOR
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2002-09-03

    (13 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMAGEN DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raichem LIPID Calibrator is intended to be used for the calibration of the Raichem LDL and HDL Cholesterol Direct assay.
    Device Description
    Not Found
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    K Number
    K021194
    Device Name
    RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2002-07-29

    (105 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMAGEN DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reagent: This reagent is intended for the quantitative in vitro measurements of C-reactive protein (CRP) in human serum or heparin and EDTA plasma. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders. Calibrator: The Raichem C-reactive Protein (CRP) Serum Calibrators are prepared from pooled human serum with added CRP purified from human pleural fluid, and are for use as calibrators in the measurement of CRP by latex turbidimetric immunoassays. Preservatives and stabilizers have been added.
    Device Description
    Not Found
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    K Number
    K022049
    Device Name
    MODIFICATION TO RAICHEM CALCIUM REAGENT
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2002-07-19

    (25 days)

    Product Code
    CJY
    Regulation Number
    862.1145
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMAGEN DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RAICHEM® Calcium Reagent ia an in vitro diagnostic intended to measure the calcium level in serum and heparinized plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetani (intermittent muscular contractions or spasms).
    Device Description
    Not Found
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    K Number
    K012649
    Device Name
    RAICHEM BUN RATE REAGENT
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2001-10-15

    (63 days)

    Product Code
    CDQ
    Regulation Number
    862.1770
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMAGEN DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This reagent is for the quantitative in vitro enzymatic determination of urea nitrogen (BUN) in serum or plasma. For in vitro diagnostic use only.
    Device Description
    Not Found
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