BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    POC-AS10 AUTO SAMPLER

    K Number: K092817 · Decision Mar 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    16
    Applicant Total
    6
    Review Days
    176

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    Basic Information

    Device Name
    POC-AS10 AUTO SAMPLER
    K Number
    K092817
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Otsuka Pharmaceutical Co., Ltd.
    Date Received
    September 14, 2009
    Decision Date
    March 9, 2010
    Product Code
    MSQ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MSQ Test, Urea (Breath Or Blood)

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