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510(k) Data Aggregation

    K Number
    K220085
    Device Name
    KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
    Manufacturer
    KRONUS, Inc.
    Date Cleared
    2023-08-24

    (590 days)

    Product Code
    OIF
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    OIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the qualitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.
    Device Description
    Not Found
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    K Number
    K171731
    Device Name
    KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
    Manufacturer
    Kronus, Inc.
    Date Cleared
    2018-01-19

    (221 days)

    Product Code
    OIF
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    OIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the quantitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.
    Device Description
    Not Found
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    K Number
    K073590
    Device Name
    KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2008-04-10

    (112 days)

    Product Code
    OIF
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    OIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS IA-2 Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to tyrosine phosphatase (1A-2) in human serum. The KRONUS IA-2 Autoantibody RIA Assay is useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
    Device Description
    Not Found
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