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

    ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING

    K Number: K972772 · Decision Jul 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    56
    Review Days
    719

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    Basic Information

    Device Name
    ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING
    K Number
    K972772
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trek Diagnostic Systems, Inc.
    Date Received
    July 24, 1997
    Decision Date
    July 13, 1999
    Product Code
    MJA
    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
    MJA Susceptibility Test Powders, Antimycobacterial

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