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

    QUANTA LITE INTRINSIC FACTOR ELISA

    K Number: K061841 · Decision Dec 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    138
    Review Days
    176

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    Basic Information

    Device Name
    QUANTA LITE INTRINSIC FACTOR ELISA
    K Number
    K061841
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1810
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Inova Diagnostics, Inc.
    Date Received
    June 29, 2006
    Decision Date
    December 22, 2006
    Product Code
    LIG
    Advisory Committee
    Clinical Chemistry
    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
    LIG Radioassay, Intrinsic Factor Blocking Antibody

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