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

    MARTIN-LEWIS AGAR

    K Number: K800334 · Decision Mar 3, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    82
    Applicant Total
    93
    Review Days
    18

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MARTIN-LEWIS AGAR
    K Number
    K800334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2410
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Isle Media and Sterile Products, Inc.
    Date Received
    February 14, 1980
    Decision Date
    March 3, 1980
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JTY), ordered by most recent decision date.

    InTray GC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INTRAY GC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GC BASE W/ 1% GCHI

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Isle Media and Sterile Products, Inc.

    K Number Device Name
    K831671 MODIFIED SOYBEAN CASEIN DIGEST BROTH
    K821218 CAMPY-S AGAR
    K820863 MEDIA FOR IN-VITRO DIAGNOSTIC USE
    K812798 MOTILITY GI MEDIUM
    K812796 ANAEROBIC CNA BLOOD AGAR
    K812795 ANAEROBIC BLOOD AGAR
    K812797 SCHAEDLER AGARS
    K800818 CHLAMYDOSPORE AGAR
    K800807 CORN MEAL AGAR MEDIA
    K800333 MODIFIED THAYER-MARTIN X AGAR
    Search all 93 clearances from Isle Media and Sterile Products, Inc. →