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

    LEGIONELLA CYE AGAR BASE & BCYE SUPPL

    K Number: K831469 · Decision Jun 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    69
    Applicant Total
    93
    Review Days
    33

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    Basic Information

    Device Name
    LEGIONELLA CYE AGAR BASE & BCYE SUPPL
    K Number
    K831469
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2450
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Oxoid U.S.A., Inc.
    Date Received
    May 6, 1983
    Decision Date
    June 8, 1983
    Product Code
    JSK
    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
    JSK Supplement, Culture Media

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