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

    CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE

    K Number: K831219 · Decision May 13, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    69
    Applicant Total
    67
    Review Days
    28

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    Basic Information

    Device Name
    CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE
    K Number
    K831219
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2450
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gibco Laboratories Life Technologies, Inc.
    Date Received
    April 15, 1983
    Decision Date
    May 13, 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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