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510(k) Data Aggregation

    K Number
    K020610
    Device Name
    LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
    Manufacturer
    BIO-RAD
    Date Cleared
    2002-04-22

    (56 days)

    Product Code
    DIECFR
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    The Lyphochek® Whole Blood Metals Control is a lyophilized control prepared from human whole blood with pure chemicals and stabilizers added. The control is provided in lyophilized form for increased stability.
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    K Number
    K990928
    Device Name
    LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
    Manufacturer
    BIO-RAD
    Date Cleared
    1999-04-16

    (28 days)

    Product Code
    DIE
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Lyphochek Urine Metals Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    Lyphochek Urine Metals Control is prepared from human urine with added trace elements, heavy metals and other chemical compounds. The control is provided in lyophilized form for increased stability.
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