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

    ORAL FLUID PHENCYCLIDINE

    K Number: K093989 · Decision Jan 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    183
    Review Days
    397

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    Basic Information

    Device Name
    ORAL FLUID PHENCYCLIDINE
    K Number
    K093989
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics
    Date Received
    December 24, 2009
    Decision Date
    January 25, 2011
    Product Code
    LCM
    Advisory Committee
    Unknown
    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
    LCM Enzyme Immunoassay, Phencyclidine

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