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

    PHENCYCLIDINE DIRECT BLOOD RIA KIT

    K Number: K800514 · Decision Mar 19, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    50
    Review Days
    14

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    Basic Information

    Device Name
    PHENCYCLIDINE DIRECT BLOOD RIA KIT
    K Number
    K800514
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Immunalysis Corporation
    Date Received
    March 5, 1980
    Decision Date
    March 19, 1980
    Product Code
    LCL
    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
    LCL Radioimmunoassay, Phencyclidine

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