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510(k) Data Aggregation

    K Number
    K982023
    Device Name
    PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1998-09-04

    (87 days)

    Product Code
    DAS
    Regulation Number
    866.5530
    Why did this record match?
    Product Code :

    DAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The contents of the Peliclass ™ subclass nephelometric Array® kit will allow quantitative determination of all four IgG subclasses in at least 25 samples with the Beckman Array ® Protein System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status.
    Device Description
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