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

    QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA

    K Number: K000733 · Decision May 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    138
    Review Days
    441

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    Basic Information

    Device Name
    QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
    K Number
    K000733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5785
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Inova Diagnostics, Inc.
    Date Received
    March 6, 2000
    Decision Date
    May 21, 2001
    Product Code
    NBT
    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
    NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)

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