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

    COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT

    K Number: K853009 · Decision Mar 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    48
    Applicant Total
    296
    Review Days
    231

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    Basic Information

    Device Name
    COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
    K Number
    K853009
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    July 16, 1985
    Decision Date
    March 4, 1986
    Product Code
    JSS
    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
    JSS Kit, Identification, Enterobacteriaceae

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