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

    IMMULISA INTRINSIC FACTOR ANTIBODY ELISA

    K Number: K071346 · Decision Sep 24, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    55
    Review Days
    133

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    Basic Information

    Device Name
    IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
    K Number
    K071346
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1810
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Immco Diagnostics, Inc.
    Date Received
    May 14, 2007
    Decision Date
    September 24, 2007
    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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