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510(k) Data Aggregation

    K Number
    K093137
    Device Name
    K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2010-09-28

    (358 days)

    Product Code
    NDY, JIT, JJX
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAMIYA BIOMEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY® Cystatin C Assay is for the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. FOR IN VITRO DIAGNOSTIC USE. The K-ASSAY® Cystatin C Calibrator is intended to be used for the calibration of the K-ASSAY® Cystatin C Assay. FOR IN VITRO DIAGNOSTIC USE. The K-ASSAY ® Cystatin C Control is intended for use as an assayed quality control material for monitoring the performance of cystatin C assays.
    Device Description
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    K Number
    K091486
    Device Name
    K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2010-04-29

    (345 days)

    Product Code
    DCF, JIT
    Regulation Number
    866.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAMIYA BIOMEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY® Microalbumin reagent is for the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine nids in the diagnosis of kidney dysfunction. FOR IN VITRO DIAGNOSTIC USE. K-ASSAY ® The Microalbumin Calibrator is for the calibration of the K-ASSAY® Microalbumin assay for quantifying albumin in urine speiment. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
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    K Number
    K050944
    Device Name
    K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2005-12-23

    (253 days)

    Product Code
    DBF, JIT
    Regulation Number
    866.5340
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAMIYA BIOMEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY® Ferritin (2) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Roche / Hitachi 917 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use. The K-ASSAY® Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2) Assay. For in vitro diagnostic use.
    Device Description
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    K Number
    K042241
    Device Name
    K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2004-12-10

    (113 days)

    Product Code
    DGC, JIT
    Regulation Number
    866.5510
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAMIYA BIOMEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kamiya K-ASSAY® Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The K-ASSAY® IgE Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® Total IgE Assay. For in vitro diagnostic use.
    Device Description
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    K Number
    K030687
    Device Name
    K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2003-06-27

    (114 days)

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

    KAMIYA BIOMEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay. The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® D-Dimer Assay. For in vitro diagnostic use.
    Device Description
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    K Number
    K023828
    Device Name
    K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2003-02-04

    (78 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAMIYA BIOMEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY® CRP (3) is intended to be used as a high sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay. Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases. The K-ASSAY® CRP Multi-Calibrator D is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay. The K-ASSAY® CRP Multi-Calibrator E is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay. The K-ASSAY® CRP Multi-Calibrator F is intended to be used for the calibration of the K-ASSAY® CRP (3) Assay.
    Device Description
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    K Number
    K023853
    Device Name
    K-ASSAY LP(A) CONTROLS
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2002-12-13

    (24 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAMIYA BIOMEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The H-ASSAY® Lp(a) Control Set is intended for use as an assayed quality control material for monitoring the performance of Lp(a) immunoturbidimetric assays.
    Device Description
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    K Number
    K022486
    Device Name
    K-ASSAY HS-CRP CONTROLS
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2002-08-14

    (16 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAMIYA BIOMEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY® hs-CRP Control Set is intended for use as an assayed quality control material for monitoring the performance of C-Reactive Protein immunoturbidimetric assays.
    Device Description
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    K Number
    K021660
    Device Name
    K-ASSAY LP(A) ASSAY
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2002-07-25

    (66 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAMIYA BIOMEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kamiya K-ASSAY® Lp(a) Assay is an in vitro diagnostic reagent for the quantitative determination of human Lp(a) in human serum by immunoturbidimetric assay. The test may provide in conjunction with other lipoprotein tests, the risk assessment of coronary artery disease for specific populations. The K-ASSAY ® Lp(a) Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Lp(a) Assay. For in vitro diagnostic use.
    Device Description
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    K Number
    K014293
    Device Name
    K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2002-02-19

    (53 days)

    Product Code
    DBF
    Regulation Number
    866.5340
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAMIYA BIOMEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY Ferritin assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and in the diagnosis and management of iron-related disorders such as hemochromatosis (iron overload) and iron deficiency anemia. The K-ASSAY Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY Ferritin Assay. For in vitro diagnostic use.
    Device Description
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