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

    COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN

    K Number: K961824 · Decision Jul 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    36
    Applicant Total
    296
    Review Days
    74

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    Basic Information

    Device Name
    COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
    K Number
    K961824
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5040
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    May 10, 1996
    Decision Date
    July 23, 1996
    Product Code
    DCF
    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
    DCF Albumin, Antigen, Antiserum, Control

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