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

    LYFO(TM) DIFFERENTIAL DISK

    K Number: K945489 · Decision May 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    17
    Applicant Total
    18
    Review Days
    184

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    Basic Information

    Device Name
    LYFO(TM) DIFFERENTIAL DISK
    K Number
    K945489
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microbiologics, Inc.
    Date Received
    November 8, 1994
    Decision Date
    May 11, 1995
    Product Code
    JSP
    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
    JSP Kit, Anaerobic Identification

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