BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY

    K Number: K042411 · Decision Apr 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    212

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    Basic Information

    Device Name
    ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
    K Number
    K042411
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3840
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axis-Shield , Ltd.
    Date Received
    September 7, 2004
    Decision Date
    April 7, 2005
    Product Code
    NRP
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NRP Sirolimus Test System

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    Other Clearances by Axis-Shield , Ltd.

    K Number Device Name
    K001981 DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500