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510(k) Data Aggregation

    K Number
    K042767
    Device Name
    DATAPRO CLINICAL CHELISTRY ANALYZER
    Manufacturer
    THERMO ELECTRON CORPORATION
    Date Cleared
    2005-04-27

    (204 days)

    Product Code
    CFR, CDO, CDQ, CDT, CEK, CEO, CGX, CHH, CIC, CIG, CIT, CIX, CJE, CKA, JJE
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataPro™ is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories. The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is intended to be used in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae related to the measurement of various clinical assays, such as Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Urea Nitrogen (BJ N), Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, Phosphorus, Total Billirubin, Total Protein, Triglyceride, and Uric Acid. The DataPro™, and all of the reagents included in this test system are for in vitro diagnostic use only.
    Device Description
    The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataPro™ is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories.
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    K Number
    K041657
    Device Name
    THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
    Manufacturer
    THERMO ELECTRON CORPORATION
    Date Cleared
    2004-08-30

    (73 days)

    Product Code
    KQN, JIS, JJX
    Regulation Number
    862.1090
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. The Thermo Electron Infinity™ ACE Reagent Kit is intended for the quantitative determination of ACE in human serum or plasma. The product is for in vitro diagnostic use only. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher`s disease, a hereditary disorder affecting the spleen. 2. The Thermo Electron Infinity™ ACE Calibrator is intended for the calibration of ACE assays. The product is for in vitro diagnostic use only. 3. The Thermo Electron ACE Normal and Elevated Controls are intended for monitoring the accuracy and precision of ACE assays. The product is for in vitro diagnostic use only.
    Device Description
    Not Found
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