BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OPUS(R) SEROLOGY CONTROLS, MODIFICATION

    K Number: K934137 · Decision Mar 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    6
    Applicant Total
    35
    Review Days
    194

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    Basic Information

    Device Name
    OPUS(R) SEROLOGY CONTROLS, MODIFICATION
    K Number
    K934137
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pb Diagnostic Systems, Inc.
    Date Received
    August 25, 1993
    Decision Date
    March 7, 1994
    Product Code
    MJX
    Advisory Committee
    Clinical Chemistry
    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
    MJX Kit, Serological, Positive Control

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