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

    EZ-SCREEN:PCP

    K Number: K943711 · Decision Sep 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    7
    Review Days
    39

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    Basic Information

    Device Name
    EZ-SCREEN:PCP
    K Number
    K943711
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Editek, Inc.
    Date Received
    August 1, 1994
    Decision Date
    September 9, 1994
    Product Code
    LCM
    Advisory Committee
    Unknown
    Review Advisory Committee
    TX
    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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    Other Clearances by Editek, Inc.

    K Number Device Name
    K963692 VERDICT PCP
    K963233 EZ-SCREEN PROFILE
    K963516 VERDICT THC
    K963529 VERDICT BARBITURATES
    K943712 VERDICT OPIATES
    K943710 VERDICT COCAINE