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

    LYFO(TM) DIFFERENTIAL DISK-STERILE DISK

    K Number: K945881 · Decision Apr 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    243
    Applicant Total
    10
    Review Days
    144

    Basic Information

    Device Name
    LYFO(TM) DIFFERENTIAL DISK-STERILE DISK
    K Number
    K945881
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MICRO BIO LOGICS, INC.
    Date Received
    December 1, 1994
    Decision Date
    April 24, 1995
    Product Code
    JTO
    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
    JTO Discs, Strips And Reagents, Microorganism Differentiation

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