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

    QUANTA LITE SP100 ELISA

    K Number: K050662 · Decision Jun 13, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    138
    Review Days
    90

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    Basic Information

    Device Name
    QUANTA LITE SP100 ELISA
    K Number
    K050662
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5090
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Inova Diagnostics, Inc.
    Date Received
    March 15, 2005
    Decision Date
    June 13, 2005
    Product Code
    NUM
    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
    NUM Autoantibodies, Nuclear Body Protein, Sp100

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