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

    MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226

    K Number: K871541 · Decision Apr 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    82
    Applicant Total
    67
    Review Days
    9

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    Basic Information

    Device Name
    MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226
    K Number
    K871541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2410
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gibco Laboratories Life Technologies, Inc.
    Date Received
    April 20, 1987
    Decision Date
    April 29, 1987
    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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