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

    TINA-QUANT ALBUMIN GEN.2

    K Number: K113072 · Decision May 14, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    36
    Applicant Total
    5
    Review Days
    210

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    Basic Information

    Device Name
    TINA-QUANT ALBUMIN GEN.2
    K Number
    K113072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5040
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Operations
    Date Received
    October 17, 2011
    Decision Date
    May 14, 2012
    Product Code
    DCF
    Advisory Committee
    Immunology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DCF Albumin, Antigen, Antiserum, Control

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