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510(k) Data Aggregation

    K Number
    K053211
    Device Name
    RDI HSFERRITIN KIT
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2006-03-13

    (117 days)

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

    REFERENCE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. The RDI Ferritin Kit is for the quantitative determination of Ferritin in luman serum or plasma by immunoturbidimetric measurement. Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis.
    Device Description
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    K Number
    K053291
    Device Name
    FERRITIN CALIBRATOR SET, CATALOG NO. 8203
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2006-03-13

    (108 days)

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

    REFERENCE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RDI Ferritin Calibrator Set is intended for medical purposes for use with the RDI Ferritin Kit to establish points of reference that are used in the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement.
    Device Description
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    K Number
    K052148
    Device Name
    TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2005-11-09

    (93 days)

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

    REFERENCE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RDI Direct TIBC Calibrator Set is intended for medical purposes for use with the RDI Direct TIBC Kit to establish points of reference that are used in the quantitative determination of Total Iron-Binding Capacity (TIBC) in human serum.
    Device Description
    Not Found
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    K Number
    K030044
    Device Name
    EXTENDED RANGE HS CRP KIT, CAT NO:9200
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2003-09-30

    (267 days)

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

    REFERENCE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. The RDI Extended Range hs CRP Kit is for the quantitative determination of C-reactive protein in human serum or plasma by immunoturbidimetric measurement.
    Device Description
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    K Number
    K030772
    Device Name
    RDI EXTENDED RANGE CRP CALIBRATOR SET
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2003-04-11

    (31 days)

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

    REFERENCE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. The RDI Extended Range CRP Calibrator Set is intended for medical purposes for use with the RDI Extended Range hsCRP Kit, to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement.
    Device Description
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    K Number
    K021607
    Device Name
    RDI HS CRP CALIBRATOR SET
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2002-06-27

    (42 days)

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

    REFERENCE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RDI hs CRP Calibrator Set is intended for medical purposes for use with the RDI hs CRP Kit to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement.
    Device Description
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    K Number
    K021609
    Device Name
    RDI HS CRP KIT
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2002-06-27

    (42 days)

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

    REFERENCE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. The RDI hs CRP Kit is for the quantitative determination of C-reactive protein in human serum or plasma by immunoturbidimetric measurement.
    Device Description
    Not Found
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    K Number
    K000783
    Device Name
    DIRECT TIBC CALIBRATOR
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2000-05-04

    (55 days)

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

    REFERENCE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000781
    Device Name
    DIRECT TIBC KIT
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    2000-05-02

    (53 days)

    Product Code
    JMO
    Regulation Number
    862.1415
    Why did this record match?
    Applicant Name (Manufacturer) :

    REFERENCE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990216
    Device Name
    MAGNETIC TIBC KIT
    Manufacturer
    REFERENCE DIAGNOSTICS, INC.
    Date Cleared
    1999-02-16

    (25 days)

    Product Code
    JMO
    Regulation Number
    862.1415
    Why did this record match?
    Applicant Name (Manufacturer) :

    REFERENCE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. The Magnetic TIBC Kit quantitatively measures total iron-biding capacity in serum.
    Device Description
    Not Found
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