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510(k) Data Aggregation

    K Number
    K021162
    Device Name
    AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2002-08-30

    (141 days)

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

    SIGMA DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMAX Destiny™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
    Device Description
    The AMAX Destiny™ Coagulation Analyzer is an automated random access multipurpose analyzer. The AMAX Destiny™ Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX Destiny™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III) and for microparticle agglutination assays such as d-dimer.
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    K Number
    K020109
    Device Name
    SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2002-02-06

    (26 days)

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

    SIGMA DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sigma Diagnostics ACCUCLOT™ LA Control is a human plasma control that is suitable for use as a positive control for lupus anticoagulant testing such as activated partial prothrombin time (APTT) and dilute Russell's viper venom time (dRVVT). Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
    Device Description
    Sigma Diagnostics ACCUTROL™ LA Control is a lyophilized human plasma based product. After reconstitution with water, ACCUTROL™ LA Control is stable for 48 hours when stored at 2-8°C and 4 weeks when stored at -20°C.
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    K Number
    K013549
    Device Name
    SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2001-12-26

    (63 days)

    Product Code
    DAP
    Regulation Number
    864.7320
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIGMA DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma calibrator that is suitable for use as calibrator for the Sigma Diagnostics AUTO D-Dimer kit Procedure CRS126 for the quantitative determination of fibrin degradation products containing Ddimer in citrated human plasma in D-dimer agglutination assays.
    Device Description
    Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma control that is suitable for use as a calibrator in the Sigma Diagnostics AUTO D-dimer assay. Sigma Diagnostics AUTO D-Dimer Calibrator is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Calibrator is stable for 3 days when stored at 2-8°C and 8 hours when stored at 18-26°C.
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    K Number
    K013544
    Device Name
    SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2001-11-15

    (22 days)

    Product Code
    DAP
    Regulation Number
    864.7320
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIGMA DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in Ddimer agglutination assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
    Device Description
    Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as a elevated control with patient citrated plasma in the Sigma Diagnostics AUTO D-dimer assay. Sigma Diagnostics AUTO D-Dimer Control, Level 2 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 2 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.
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    K Number
    K013545
    Device Name
    SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2001-11-15

    (22 days)

    Product Code
    DAP
    Regulation Number
    864.7320
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIGMA DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 3 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in D-dimer assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.
    Device Description
    Sigma Diagnostics AUTO D-Dimer Control, Level 3 is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Control, Level 3 is stable for 3 days when stored at 2-8°C and 24 hours when stored at 18-26°C.
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    K Number
    K012410
    Device Name
    INFINITY HBA KIT, MODELS 537-A, 537-B
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2001-10-26

    (88 days)

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

    SIGMA DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sigma Diagnostics INFINITY™ HbA1c assay is an in vitro assay for the quantitative determination of hemoglobin A1c (HbA1c) in whole blood for use on automated analyzers. Sigma Diagnostics INFINITY™ HbA1c is a device to measure the percent hemoglobin A1c in anticoagulated whole blood. Hemoglobin A1c is indicated for the monitoring of long-term glucose control in individuals with diabetes mellitus.
    Device Description
    The INFINITY HbA1c assay is a microparticle enhanced turbidimetric immunoassay.
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    K Number
    K010652
    Device Name
    SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2001-03-30

    (25 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIGMA DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010158
    Device Name
    THROMBOMAX-HS WITH CALCIUM, MODEL T6540
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2001-03-22

    (64 days)

    Product Code
    GGO
    Regulation Number
    864.7925
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIGMA DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003267
    Device Name
    SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2001-03-15

    (148 days)

    Product Code
    DAP
    Regulation Number
    864.7320
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIGMA DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003328
    Device Name
    ACCUCLOT CONTROL I, MODEL A4089
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    2001-03-01

    (128 days)

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

    SIGMA DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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