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

    ROCHE OXI/FERM II

    K Number: K923313 · Decision Apr 5, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    6
    Applicant Total
    296
    Review Days
    272

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    Basic Information

    Device Name
    ROCHE OXI/FERM II
    K Number
    K923313
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    July 7, 1992
    Decision Date
    April 5, 1993
    Product Code
    LQM
    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
    LQM Gram Negative Identification Panel

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