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510(k) Data Aggregation

    K Number
    K133519
    Device Name
    CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    2014-05-16

    (182 days)

    Product Code
    JJE, CEM, CFR, CGZ, JGS, JIX
    Regulation Number
    862.2160
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAROLINA LIQUID CHEMISTRIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carolina Liquid Chemistries CLC 6410 chemistry analyzer is an automated clinical analyzer for in vitro diagnostic use only in clinical laboratories. It is intended to be used for a variety of assay methods. The analyzer provides in vitro quantitative determinations for glucose, sodium, potassium, and chloride in serum and plasma samples. The Carolina Liquid Chemistries Glucose Reagent is for use with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the measurement of glucose in serum and plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma. The Carolina Liquid Chemistries ISE Kit is intended to be used with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for measurement of sodium, potassium, and chloride in serum and plasma. The ISE Kit consists of ISE Buffer, internal reference solution, and reference solution. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used for the diagnosis and treatment of electrolyte and metabolic disorders. The Carolina Liquid Chemistries ISE Calibrator Kit consists of Calibrator 1, Calibrator 2, and Selectivity Check. It is used with the ISE Module on the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the calibration of the Sodium, Potassium and Chloride assays. For in vitro diagnostic use only.
    Device Description
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    K Number
    K132711
    Device Name
    CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    2014-05-08

    (252 days)

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

    CAROLINA LIQUID CHEMISTRIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of high-density lipprotein cholesterol (HDL-C) in serum using the Carolina Liquid Chemistries CLC720® Clinical Chemistry Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.
    Device Description
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    K Number
    K971907
    Device Name
    CALCIUM REAGENT
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-06-24

    (32 days)

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

    CAROLINA LIQUID CHEMISTRIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Calcium Reagent is intended for the quantitative determination of serum calcium using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of hyperparathyroidism, hypoparathyroidism, multiple myeloma, nephrosis, nephritis, pancreatitis and hypervitaminosis D.
    Device Description
    Calcium Reagent
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    K Number
    K972073
    Device Name
    TOTAL BILIRUBIN REAGENT
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-06-24

    (21 days)

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

    CAROLINA LIQUID CHEMISTRIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Total Bilirubin is intended for the quantitative determination of total bilirubin in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
    Device Description
    Total Bilirubin Reagent
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    K Number
    K971324
    Device Name
    TRIGLYCERIDES, TG, OR TRIG
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-06-20

    (71 days)

    Product Code
    CDT
    Regulation Number
    862.1705
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAROLINA LIQUID CHEMISTRIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Triglycerides Reagent is intended for the quantitative determination of serum triglycerides using the Beckman SYNCHRON CX Clinical System:s. Elevated serum triglyceride levels are associated with increased risk of coronary artery disease, pancreatitis, and numerous genetic lipoprotein disorders.
    Device Description
    Not Found
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    K Number
    K971908
    Device Name
    CREA OR CREATININE
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-06-17

    (25 days)

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

    CAROLINA LIQUID CHEMISTRIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Creatinine Reagent is intended for the quantitative determination of serum creatinine using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of renal malfunction.
    Device Description
    Creatinine Reagent
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    K Number
    K971967
    Device Name
    BUN
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-06-17

    (20 days)

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

    CAROLINA LIQUID CHEMISTRIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BUN Reagent is intended for the quantitative determination of urea nitrogen in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of certain renal and metabolic diseases.
    Device Description
    Not Found
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    K Number
    K971467
    Device Name
    SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-06-16

    (55 days)

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

    CAROLINA LIQUID CHEMISTRIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Glucose Reagent is intended for the quantitative determination of serum glucose using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of diabetes mellitus, neonatal and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
    Device Description
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    K Number
    K971345
    Device Name
    CHOL OR CHOLESTEROL
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-05-29

    (49 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAROLINA LIQUID CHEMISTRIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cholesterol Reagent is intended for the quantitative determination of serum total cholesterol using Beckman SYNCHRON CX Systems. The results are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood as well as lipid and lipoprotein metabolism disorders.
    Device Description
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    K Number
    K971396
    Device Name
    CK REAGENT
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-05-29

    (44 days)

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

    CAROLINA LIQUID CHEMISTRIES CORP.

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