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

    COBAS INTEGRA REAGENT CASSETTES

    K Number: K982382 · Decision Sep 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    60
    Applicant Total
    296
    Review Days
    82

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    Basic Information

    Device Name
    COBAS INTEGRA REAGENT CASSETTES
    K Number
    K982382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    July 8, 1998
    Decision Date
    September 28, 1998
    Product Code
    CFN
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CFN Method, Nephelometric, Immunoglobulins (G, A, M)

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