BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ORTHO T. CRUZI ELISA TEST SYSTEM

    K Number: K072732 · Decision Apr 15, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    106
    Review Days
    567

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    Basic Information

    Device Name
    ORTHO T. CRUZI ELISA TEST SYSTEM
    K Number
    K072732
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3870
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho-Clinical Diagnostics, Inc.
    Date Received
    September 26, 2007
    Decision Date
    April 15, 2009
    Product Code
    MIU
    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
    MIU Enzyme Linked Immunosorbent Assay, T. Cruzi

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