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

    Access Ostase

    K Number: K232904 · Decision Apr 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    25
    Applicant Total
    8
    Review Days
    210

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    Basic Information

    Device Name
    Access Ostase
    K Number
    K232904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter
    Date Received
    September 18, 2023
    Decision Date
    April 15, 2024
    Product Code
    CIN
    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
    CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

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