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

    IMMUNOWELL EA (D) IGG TEST

    K Number: K010301 · Decision Jun 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    55
    Applicant Total
    10
    Review Days
    130

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    Basic Information

    Device Name
    IMMUNOWELL EA (D) IGG TEST
    K Number
    K010301
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genbio
    Date Received
    February 1, 2001
    Decision Date
    June 11, 2001
    Product Code
    LSE
    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
    LSE Epstein-Barr Virus, Other

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    K973939 IMMUNOWELL VCA IGM TEST
    K973941 IMMUNOWELL EBNA IGG TEST
    K963054 IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
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    K953682 IMMUNO DOT BORRELIA DOT BLOT G TEST
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