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

    EIA SMDP IMMUNOASSAY

    K Number: K132631 · Decision Aug 29, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    27
    Applicant Total
    22
    Review Days
    372

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    Basic Information

    Device Name
    EIA SMDP IMMUNOASSAY
    K Number
    K132631
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phadia US, Inc.
    Date Received
    August 22, 2013
    Decision Date
    August 29, 2014
    Product Code
    LKP
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKP Anti-Sm Antibody, Antigen And Control

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