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

    PARA-PRO FC50

    K Number: K053257 · Decision May 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    18
    Review Days
    171

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    Basic Information

    Device Name
    PARA-PRO FC50
    K Number
    K053257
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alpha-Tec Systems, Inc.
    Date Received
    November 22, 2005
    Decision Date
    May 12, 2006
    Product Code
    LKS
    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
    LKS Device, Parasite Concentration

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