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

    MARTIN & LEMIS AGAR W/VCAT INHIBITOR

    K Number: K823309 · Decision Dec 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    82
    Applicant Total
    12
    Review Days
    28

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    Basic Information

    Device Name
    MARTIN & LEMIS AGAR W/VCAT INHIBITOR
    K Number
    K823309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2410
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Troy Biologicals, Inc.
    Date Received
    November 5, 1982
    Decision Date
    December 3, 1982
    Product Code
    JTY
    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
    JTY Culture Media, For Isolation Of Pathogenic Neisseria

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