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

    BIONIKE AQ PHENCYCLIDINE (PCP) TEST

    K Number: K993945 · Decision Dec 7, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    6
    Review Days
    18

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    Basic Information

    Device Name
    BIONIKE AQ PHENCYCLIDINE (PCP) TEST
    K Number
    K993945
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionike Laboratories, Inc.
    Date Received
    November 19, 1999
    Decision Date
    December 7, 1999
    Product Code
    LCM
    Advisory Committee
    Unknown
    Review Advisory Committee
    TX
    Third Party
    Y

    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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