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

    PCP DIRECT RIA KIT (I-125)

    K Number: K913864 · Decision Oct 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    50
    Review Days
    45

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    Basic Information

    Device Name
    PCP DIRECT RIA KIT (I-125)
    K Number
    K913864
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Immunalysis Corporation
    Date Received
    August 27, 1991
    Decision Date
    October 11, 1991
    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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