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510(k) Data Aggregation

    K Number
    K121794
    Device Name
    LIQUICHEK URINE CHEMISTRY CONTROL
    Manufacturer
    BIO-RAD, DIAGNOSTICS GRP.
    Date Cleared
    2012-07-11

    (22 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-RAD, DIAGNOSTICS GRP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquichek Urine Chemistry 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
    Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
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    K Number
    K100727
    Device Name
    LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK
    Manufacturer
    BIO-RAD, DIAGNOSTICS GRP.
    Date Cleared
    2010-09-14

    (183 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-RAD, DIAGNOSTICS GRP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquid Assayed Multiqual is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
    Device Description
    Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.
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    K Number
    K072721
    Device Name
    LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
    Manufacturer
    BIO-RAD, DIAGNOSTICS GRP.
    Date Cleared
    2007-12-11

    (76 days)

    Product Code
    DIF, REG
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-RAD, DIAGNOSTICS GRP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lyphochek Whole Blood Immunosuppressant Controls is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Sirolimus, Tacrolimus, Cyclosporine. Abbott Immunosuppressant MCC is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Sirolimus, Tacrolimus.
    Device Description
    Lyphochek Whole Blood Immunosuppressant Controls and Abbott Immunosuppressant MCC are both prepared from human whole blood, with added chemicals, and stabilizers.
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    K Number
    K072835
    Device Name
    LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
    Manufacturer
    BIO-RAD, DIAGNOSTICS GRP.
    Date Cleared
    2007-12-11

    (69 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-RAD, DIAGNOSTICS GRP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquichek Microalbumin Control is intended for use as an assayed quality control urine to monitor the precision of laboratory procedures listed in the package insert. Liquichek Microalbumin Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    Liquichek Microalbumin Control is prepared from human urine with added constituents of human, pure chemicals, preservatives and stabilizers. The contral is provided in Iliginal form for convenience.
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    K Number
    K071319
    Device Name
    I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
    Manufacturer
    BIO-RAD, DIAGNOSTICS GRP.
    Date Cleared
    2007-06-26

    (47 days)

    Product Code
    GGN, REG
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-RAD, DIAGNOSTICS GRP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    i-STAT® Activated Clotting Time (ACT) Control is used to verify the integrity of newly received i-STAT® Activated Clotting Time cartridges.
    Device Description
    This is a lyophilized product prepared from human plasma, with added purified I mo to a ly ophilizes. The control is provided in lyophilized form for increased stability.
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    K Number
    K070848
    Device Name
    LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X
    Manufacturer
    BIO-RAD, DIAGNOSTICS GRP.
    Date Cleared
    2007-04-25

    (28 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-RAD, DIAGNOSTICS GRP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in the package insert.
    Device Description
    Liquichek Urinalysis Control is prepared from human urine with added human erythrocytes, simulated leukocytes, constituents of animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
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