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

    MARTIN LEWIS AGAR

    K Number: K850722 · Decision Mar 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    82
    Applicant Total
    10
    Review Days
    28

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    Basic Information

    Device Name
    MARTIN LEWIS AGAR
    K Number
    K850722
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2410
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Rapid City Regional Hospital, Inc.
    Date Received
    February 22, 1985
    Decision Date
    March 22, 1985
    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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    Other Clearances by Rapid City Regional Hospital, Inc.

    K Number Device Name
    K850724 CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL
    K850719 DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR
    K850717 AMIES TRANSPORT MEDIA
    K850721 KLIGER'S IRON AGAR, SIM MEDIA, MRVP MEDIUM, BILE E
    K850723 SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC
    K850715 MUELLER HINTON AGAR
    K850720 EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5%
    K850716 SELENITE F BROTH
    K850718 CORN MEAL AGAR