BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OPUS CMV TEST SYSTEM

    K Number: K905257 · Decision Apr 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    16
    Applicant Total
    35
    Review Days
    147

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    Basic Information

    Device Name
    OPUS CMV TEST SYSTEM
    K Number
    K905257
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Pb Diagnostic Systems, Inc.
    Date Received
    November 21, 1990
    Decision Date
    April 17, 1991
    Product Code
    LIN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LIN Antisera, Conjugated Fluorescent, Cytomegalovirus

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