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

    PRESAGE ST2 ASSAY

    K Number: K111452 · Decision Dec 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    198

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    Basic Information

    Device Name
    PRESAGE ST2 ASSAY
    K Number
    K111452
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1117
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Critical Care Diagnostics, Inc. (Dba Critical Diag
    Date Received
    May 25, 2011
    Decision Date
    December 9, 2011
    Product Code
    OYG
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OYG St2 Assay