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510(k) Data Aggregation

    K Number
    K955363
    Device Name
    INCSTAR HSZ I/II IGG ELISA ASSAY
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-07-24

    (245 days)

    Product Code
    IGC
    Regulation Number
    864.4010
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INCSTAR HSZ I/II IGG ELISA ASSAY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text segments are either in a non-English language (Khmer, Arabic, Hindi, Japanese as identified by optical character recognition) or contain a lot of noise and fragmented characters that prevent me from understanding the content.

    Therefore, I cannot extract any information related to acceptance criteria, device performance, study details, expert qualifications, or ground truth establishment to answer your request.

    If you can provide the input in a clear, English-readable format, I would be happy to assist you in describing the acceptance criteria and study details.

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