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510(k) Data Aggregation

    K Number
    K062120
    Device Name
    CISBIO RENIN RIA TEST
    Manufacturer
    CIS BIO INTERNATIONAL
    Date Cleared
    2007-03-30

    (248 days)

    Product Code
    CIB
    Regulation Number
    862.1085
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CISBIO RENIN RIA TEST

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

    A radioimmunoassay for the quantitative in vitro diagnostic measurement of the level of renin in plasma. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a Renin RIA Test. This document does not describe acceptance criteria, device performance, or details of a study that proves the device meets specific acceptance criteria in the way described in the request (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies). It is a regulatory approval letter for an in vitro diagnostic device, not a technical report on its performance validation.

    Therefore, I cannot extract the requested information from the provided text.

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