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510(k) Data Aggregation

    K Number
    K063145
    Device Name
    PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2007-10-17

    (366 days)

    Product Code
    DIP, DKB
    Regulation Number
    862.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Phenytoin is intended for in vitro diagnostic use in the quantitative determination of the phenytoin concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy. TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981647 Phenytoin assay on T60 Analyzer.
    Device Description
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    K Number
    K063705
    Device Name
    LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2007-10-09

    (300 days)

    Product Code
    NDW, DKB, JIX, KLS
    Regulation Number
    862.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lithium is intended for in vitro diagnostic use in the quantitative determination of the lithium concentration in human serum on T60 Clinical Chemistry Analyzers. Measurements are used as an aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). Theophylline is intended for quantitative in vitro diagnostic determination of the theophylline concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to help ensure proper therapy. The ISE Calibrators 1 and 2 & 3 are intended for calibration of ion selective electrodes for quantitative measurements of potassium, sodium and chloride in human serum or plasma and lithium in human serum. For the in vitro diagnostic use on the T60 analyzer. TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981649 Theophylline assay on T60 Analyzer.
    Device Description
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    K Number
    K063131
    Device Name
    CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2007-10-05

    (357 days)

    Product Code
    KLT, DKB, LEG
    Regulation Number
    862.3645
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carbamazepine is intended for the quantitative in vitro diagnostic determination of the carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy. The Valproic Acid is intended for the quantitative in vitro diagnostic determination of the valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy. TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer.
    Device Description
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    K Number
    K063838
    Device Name
    LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2007-09-27

    (275 days)

    Product Code
    DFC, JIT, JJY
    Regulation Number
    866.5600
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the in vitro quantitative determination of the Lipoprotein(a) in human serum, Liheparin plasma and EDTA plasma on T60 instruments. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify specific populations at risk from cardiovascular diseases Lipoprotein(a) Calibrator is used as a calibrator for quantification of Lipoprotein(a) in serum and plasma by immunoturbidimetry with T60 instruments using methods defined by Thermo Electron Oy For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control High is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy.
    Device Description
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    K Number
    K063086
    Device Name
    TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2007-08-08

    (302 days)

    Product Code
    DDG, JIX, JJY
    Regulation Number
    866.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The transferrin test system is intended for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical chemistry Analyzers. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, acute infection and iron deficiency anemia. SpeciCal protein calibrator is used as a stock calibrator for both quantification of specific proteins in serum and plasma by immunoturbidimetry and for antigen excess detection using methods defined by Thermo Electron Oy SpeciTrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Ov Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy
    Device Description
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    K Number
    K063209
    Device Name
    HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2007-03-21

    (149 days)

    Product Code
    LCP, JJX, KRZ
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hemoglobin A1c (HbA1c) test system with associated calibrators and controls is intended for quantitative in-vitro diagnostic determination of the hemoglobin A1c (HbA1c) concentration as a percentage of total hemoglobin in human whole blood using T60 Clinical Chemistry Analyzers. Measurement of percent HbA1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
    Device Description
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    K Number
    K063150
    Device Name
    COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2007-03-19

    (154 days)

    Product Code
    CZW, DBI, JIX, JJY
    Regulation Number
    866.5240
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use in the quantitative determination of the complement C3 concentration in human serum on the T60 analyzer. For in vitro diagnostic use in the quantitative determination of the complement C4 concentration in human serum on the T60 analyzer. The complement C3 and complement C4 are intended for quantative in-vitro diagnostic determination of the complement C3 and C4 concentration in human serum using T60 Clinical Chemistry Analyzers. C3 and C4 measurements may aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
    Device Description
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    K Number
    K063647
    Device Name
    CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2007-03-12

    (95 days)

    Product Code
    NDY, JIT, JJX
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cystatin C is intended for quantitative in-vitro diagnostic determination of Cystatin C in human serum or Li-heparin plasma and EDTA plasma by turbidimetry using T60 Clinical Chemistry Analyzers. Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases. Cystatin C Calibrator is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Calibrator is used as a calibrator for quantification of Cystatin C in serum and plasma by immunoturbidimetry using methods defined by Thermo Electron Oy. Cystatin C Control is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Control is used as a quality control to monitor precision of the Cystatin C test using methods defined by Thermo Electron Oy. Cystatin C Control High is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Control High is used as a quality control serum to monitor precision of the Cystatin C test using methods defined by Thermo Electron Oy.
    Device Description
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    K Number
    K061107
    Device Name
    DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2006-08-08

    (110 days)

    Product Code
    CEM, CFR, CGZ, JGS, JIX, JJE, JJY
    Regulation Number
    862.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers are fully automated random access analyzers for in-vitro diagnostic use with clinical laboratory assays validated for use on these instrument platforms, including an ISE unit with Na+, K+ and CI- electrodes. The DPC T60 Glucose (HK) test system with associated Calibrators and Controls is intended for quantitative in-vitro diagnostic determination of glucose in serum or plasma using the DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoqlycemia, and of pancreatic islet cell carcinoma. The DPC ISE Micro Volume Chloride, Potassium and Sodium Electrodes with associated Calibrators are intended for quantitative in-vitro diagnostic determination of Chloride, Potassium and Sodium in serum or plasma using the DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
    Device Description
    The DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers are fully automated random access analyzers for in-vitro diagnostic use with clinical laboratory assays validated for use on these instrument platforms, including an ISE unit with Na+, K+ and CI- electrodes.
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