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

    REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK

    K Number: K970831 · Decision Apr 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    327
    Applicant Total
    17
    Review Days
    26

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    Basic Information

    Device Name
    REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
    K Number
    K970831
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1620
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Remel, Inc.
    Date Received
    March 7, 1997
    Decision Date
    April 2, 1997
    Product Code
    JTN
    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
    JTN Susceptibility Test Discs, Antimicrobial

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