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510(k) Data Aggregation

    K Number
    K192730
    Device Name
    CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
    Manufacturer
    BioSystems S.A.
    Date Cleared
    2020-09-09

    (348 days)

    Product Code
    CHW, CDQ, CGA
    Regulation Number
    862.1145
    Why did this record match?
    Product Code :

    CHW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CALCIUM-CRESOLPHTHALEIN: Reagent for the measurement of calcium concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. GLUCOSE: Reagent for the measurement of glucose concentration in human serum and plasma. The obtained values are useful as an aid in the diagnosis and treatment of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. UREA/BUN - UV: Reagent for the measurement of urea concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of certain renal and metabolic diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
    Device Description
    Not Found
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    K Number
    K113521
    Device Name
    CALCIUM GEN. 2
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2012-05-08

    (161 days)

    Product Code
    CHW
    Regulation Number
    862.1145
    Why did this record match?
    Product Code :

    CHW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Calcium Gen.2 assay is an in vitro diagnostics reagent system intended for the quantitative determination of calcium in human serum, plasma, and urine on Roche/Hitachi cobas c systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.
    Device Description
    The Calcium Gen. 2 test system employs a photometric test method where calcium ions react with a calcium specific polyamino carboxylic acid under alkaline conditions to form a complex. This complex reacts in the second step with EDTA. The calcium concentration is directly proportional to the change in absorbance which is measured photometrically.
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