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

    ADVIA CENTAUR HAVM ASSAY

    K Number: K081716 · Decision Jul 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    25
    Applicant Total
    152
    Review Days
    29

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    Basic Information

    Device Name
    ADVIA CENTAUR HAVM ASSAY
    K Number
    K081716
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3310
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    June 18, 2008
    Decision Date
    July 17, 2008
    Product Code
    LOL
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LOL Hepatitis A Test (Antibody And Igm Antibody)

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