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    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇷 Argentina

    WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254

    K Number: K023889 · Decision Feb 11, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    24
    Review Days
    447

    Basic Information

    Device Name
    WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
    K Number
    K023889
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3870
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    WIENER LABORATORIES S.A.I.C.
    Date Received
    November 21, 2002
    Decision Date
    February 11, 2004
    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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