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

    ALAMAR BACTERIAL IDENTIFICATION TEST PANEL

    K Number: K926002 · Decision Sep 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    48
    Applicant Total
    26
    Review Days
    300

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    Basic Information

    Device Name
    ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
    K Number
    K926002
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alamar Biosciences Laboratory, Inc.
    Date Received
    November 27, 1992
    Decision Date
    September 23, 1993
    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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