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

    BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST

    K Number: K895362 · Decision Dec 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    13
    Applicant Total
    632
    Review Days
    94

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    Basic Information

    Device Name
    BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
    K Number
    K895362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    August 29, 1989
    Decision Date
    December 1, 1989
    Product Code
    JTT
    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
    JTT Susceptibility Test Powders, Antimicrobial

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