BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    VIDAS NEPHROCHECK

    K Number: K210793 · Decision Jul 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    479

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    Basic Information

    Device Name
    VIDAS NEPHROCHECK
    K Number
    K210793
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1220
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomérieux SA
    Date Received
    March 16, 2021
    Decision Date
    July 8, 2022
    Product Code
    PIG
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PIG Acute Kidney Injury Test System

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    Other Clearances by Biomérieux SA

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