BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ARCHITECT SIROLIMUS ASSAY

    K Number: K070822 · Decision Sep 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    20
    Review Days
    186

    Basic Information

    Device Name
    ARCHITECT SIROLIMUS ASSAY
    K Number
    K070822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3840
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FUJIREBIO DIAGNOSTICS, INC.
    Date Received
    March 26, 2007
    Decision Date
    September 28, 2007
    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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